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510(k) K843475

PHARMA-PLAST SINGLE USE OVERSHOES by Zimmar Consulting , Ltd. — Product Code FXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1984
Date Received
September 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Shoe, Operating-Room
Device Class
Class I
Regulation Number
878.4040
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)
  • K843469 — PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- (November 19, 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)
  • K843473 — PHARMA-PLAST INSULIN SYRINGE (October 31, 1984)
  • K843472 — PHARMA-PLAST SYRINGE WITH NEEDLE (October 31, 1984)

Other clearances for product code FXP

  • K971076 — PRIMED SHOE COVERS, PRIMED HEAD COVERS (January 13, 1998)
  • K971191 — FAR-EAST SHOE COVERS (July 10, 1997)
  • K970815 — CONVERTORS IMPERVIOUS SHOE COVERS (March 27, 1997)
  • K961342 — SHOE COVER, NON-STERILE (December 30, 1996)
  • K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH (November 19, 1996)
  • K952897 — NIOMED SHOE COVERS (October 23, 1995)
  • K952937 — NIOMED NON-SKID SHOE COVERS (October 23, 1995)
  • K943034 — OREX SHOE COVERS (January 2, 1995)
  • K932738 — KAPPLER PRO/VENT BOOT (March 29, 1994)
  • K925815 — REUSABLE LIQUIDPROOF BOOTIE (July 9, 1993)