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510(k) K843469

PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- by Zimmar Consulting , Ltd. — Product Code JOL

K843469 is an FDA 510(k) premarket notification submitted by Zimmar Consulting , Ltd. for the device "PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-". The FDA issued a decision of Substantially Equivalent on November 19, 1984. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Zimmar Consulting , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1984
Date Received
September 6, 1984
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 Zimmar Consulting , Ltd.

  • K860322 — CLINISET INFUSION SET (April 7, 1986)
  • K843477 — PHARMA-PLAST RECTAL TIP (December 5, 1984)
  • K843478 — PHARMA-PLAST URIDROP-URIDOME (December 5, 1984)
  • K843468 — PHARMA-PLAST SUCTION SET TYPE YANKAUER (November 23, 1984)
  • K843466 — PHARMA-PLAST OXYGEN CATHETER (November 19, 1984)
  • K843467 — PHARMA-PLAST NASAL OXYGEN CANNULA (November 19, 1984)
  • K843470 — PHARMA-PLAST CONNECTING TUBE TYPE SUCT- (November 16, 1984)
  • K843475 — PHARMA-PLAST SINGLE USE OVERSHOES (October 31, 1984)
  • K843472 — PHARMA-PLAST SYRINGE WITH NEEDLE (October 31, 1984)
  • K843471 — PHARMA-PLAST SYRINGE (October 31, 1984)

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