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510(k) K904216

STERILE WATER SOLUTION CATALOG # 10000 by Superior Healthcare Group, Inc. — Product Code JOL

K904216 is an FDA 510(k) premarket notification submitted by Superior Healthcare Group, Inc. for the device "STERILE WATER SOLUTION CATALOG # 10000". The FDA issued a decision of Substantially Equivalent on November 16, 1990. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Superior Healthcare Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1990
Date Received
September 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter And Tip, Suction
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Superior Healthcare Group, Inc.

  • K925530 — INSTRUMENT WARMER (June 18, 1993)
  • K924764 — OVERTUBE FOR ENDSCOPIC LIGATOR (March 15, 1993)
  • K905755 — NON-STERILE PATIENT EXAMINATION GLOVES (March 8, 1991)
  • K903347 — SODIUM CHLORIDE SOLUTION (December 13, 1990)
  • K903340 — STERILE URETHRAL CATHETER PROCEDURE KITS (October 4, 1990)
  • K896321 — NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. (November 13, 1989)
  • K894676 — STERILE LATEX EXAM GLOVES (August 17, 1989)
  • K891445 — LATEX EXAMINATION GLOVES (August 9, 1989)
  • K892426 — NO. 86500 - ENDOSCOPIC JET WASHER (June 22, 1989)
  • K885339 — FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT (March 1, 1989)

Other clearances for product code JOL

  • K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F (August 12, 2005)
  • K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (July 12, 2001)
  • K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (July 12, 2001)
  • K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
  • K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (October 25, 2000)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (March 9, 1998)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (March 9, 1998)
  • K974397 — STERILE SALINE FOR CATHETER CARE (February 10, 1998)
  • K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (February 5, 1998)
  • K972372 — GERM TRAPPER SUCTION TUBE HOLDER (December 11, 1997)

FDA data resources