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510(k) K971076

PRIMED SHOE COVERS, PRIMED HEAD COVERS by Primeline Medical Products, Inc. — Product Code FXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1998
Date Received
March 24, 1997
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 Primeline Medical Products, Inc.

  • K022868 — PRIMAGARD SURGICAL EQUIPMENT DRAPES (November 8, 2002)
  • K023266 — PRIMAGARD SURGICAL GOWNS (November 8, 2002)
  • K023117 — PRIMAGARD SURGICAL GOWNS (November 8, 2002)
  • K021864 — PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1- (September 23, 2002)
  • K021076 — PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGI (April 16, 2002)
  • K011789 — PROCEDURE MASKS: PM4-301 AND PM4-304 (June 22, 2001)
  • K001951 — PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCED (September 8, 2000)
  • K971075 — PRIMED PRIME-PLUS COTTON GAUZE SPONGES (June 22, 1997)

Other clearances for product code FXP

  • 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)
  • K914702 — STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS (January 29, 1993)