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510(k) K932738

KAPPLER PRO/VENT BOOT by Kappler, Inc. — Product Code FXP

K932738 is an FDA 510(k) premarket notification submitted by Kappler, Inc. for the device "KAPPLER PRO/VENT BOOT". The FDA issued a decision of Substantially Equivalent on March 29, 1994. The device falls under product code FXP (Cover, Shoe, Operating-Room), a Class I device regulated under 21 CFR 878.4040. Kappler, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1994
Date Received
June 7, 1993
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 Kappler, Inc.

  • K932694 — KAPPLER PRO/VENT PROCEDURE GOWN (March 29, 1994)

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)
  • K952937 — NIOMED NON-SKID SHOE COVERS (October 23, 1995)
  • K952897 — NIOMED SHOE COVERS (October 23, 1995)
  • K943034 — OREX SHOE COVERS (January 2, 1995)
  • K925815 — REUSABLE LIQUIDPROOF BOOTIE (July 9, 1993)
  • K914702 — STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS (January 29, 1993)

FDA data resources