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510(k) K893702

TECNOL GAITERS PRODUCT NUMBER 47725-010 by Tecnol New Jersey Wound Care, Inc. — Product Code FXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
May 18, 1989
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 Tecnol New Jersey Wound Care, Inc.

  • K913043 — MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS (August 23, 1991)
  • K911891 — FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK (July 12, 1991)
  • K911907 — FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS (July 8, 1991)
  • K896193 — TECNOL LAZER(TM) SURGICAL MASK (February 27, 1990)
  • K894205 — TECNOL SILK STRIP (July 25, 1989)
  • K891187 — TECNOL NASO-GASTRIC TUBE HOLDER (May 30, 1989)
  • K891178 — TECNOL SECURE-ALL TUBE HOLDER (May 23, 1989)
  • K884440 — TECNOL VARIABLE TENSION BANDAGE (January 17, 1989)
  • K882640 — TECNOL SECURE-ALL PELVIC TRACTION BELT (July 27, 1988)
  • K882641 — TECNOL CATHETER LEG STRAP (July 12, 1988)

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)