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510(k) K943661

STERILE PHYSIOLOGICAL SALINE/STERILE WATER by Medcare Custom Packaging, Inc. — Product Code JOL

K943661 is an FDA 510(k) premarket notification submitted by Medcare Custom Packaging, Inc. for the device "STERILE PHYSIOLOGICAL SALINE/STERILE WATER". The FDA issued a decision of Substantially Equivalent on April 10, 1995. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Medcare Custom Packaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1995
Date Received
July 28, 1994
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 Medcare Custom Packaging, Inc.

  • K954869 — MEDCARE YANKAUER SUCTION DEVICE (January 19, 1996)
  • K954442 — STERILE ISOTONIC SALINE & STERILE WATER (December 21, 1995)
  • K952759 — TOWEL PACK (September 29, 1995)
  • K950390 — URETHRAL CATHETERIZATION TRAY (May 30, 1995)
  • K951149 — SINGLE USE INSTRUMENT TRAY (April 6, 1995)
  • K934732 — PELVIC EXAM TRAY (December 30, 1994)
  • K942000 — BURN DRESSING TRAY (May 20, 1994)
  • K936261 — CATHETER INSERTION TRAY (March 10, 1994)
  • K922179 — CATHETER INSERTION TRAY (July 2, 1993)
  • K901856 — CUSTOM WOUND MANAGEMENT KITS AND TRAYS (August 1, 1990)

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)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (March 9, 1998)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 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