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510(k) K961342

SHOE COVER, NON-STERILE by Copioumed Intl., Inc. — Product Code FXP

K961342 is an FDA 510(k) premarket notification submitted by Copioumed Intl., Inc. for the device "SHOE COVER, NON-STERILE". The FDA issued a decision of Substantially Equivalent on December 30, 1996. The device falls under product code FXP (Cover, Shoe, Operating-Room), a Class I device regulated under 21 CFR 878.4040. Copioumed Intl., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1996
Date Received
March 20, 1996
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 Copioumed Intl., Inc.

  • K030927 — POWDERED VINYL EXAM GLOVES, WHITE (April 17, 2003)
  • K021961 — POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE (July 2, 2002)
  • K021743 — (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW (June 10, 2002)
  • K972624 — POLY (VINYL) EXAM GLOVE, POWDER-FREE (November 6, 1997)
  • K971316 — POLY (VINYL) EXAM GLOVE, POWDERED (August 27, 1997)
  • K965237 — NURSES BOUFFANT CAP (August 27, 1997)
  • K960999 — ISOLATION GOWN (December 30, 1996)

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)
  • 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)
  • 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)

FDA data resources