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510(k) K874064

SHOE COVERS by Interpro Intl., Inc. — Product Code FXP

K874064 is an FDA 510(k) premarket notification submitted by Interpro Intl., Inc. for the device "SHOE COVERS". The FDA issued a decision of Substantially Equivalent on November 4, 1987. The device falls under product code FXP (Cover, Shoe, Operating-Room), a Class I device regulated under 21 CFR 878.4040. Interpro Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1987
Date Received
October 5, 1987
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 Interpro Intl., Inc.

  • K890968 — VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX) (July 31, 1989)
  • K891642 — PATIENT EXAMINATION GLOVES (LATEX) (July 14, 1989)
  • K890891 — LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL) (July 14, 1989)
  • K891440 — PATIENT EXAMINATION GLOVES (LATEX) (May 31, 1989)
  • K891438 — PATIENT EXAMINATION GLOVES (LATEX) (May 31, 1989)
  • K881374 — SURGEONS GLOVES (August 5, 1988)
  • K874067 — GUAZE SPONGES (December 14, 1987)
  • K874766 — INTERPRO INT'L, INC. ISOLATION GOWN (December 10, 1987)
  • K874065 — LAPAROTOMY SPONGES (November 4, 1987)
  • K874066 — SURGICAL CAPS (November 4, 1987)

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)
  • K932738 — KAPPLER PRO/VENT BOOT (March 29, 1994)
  • K925815 — REUSABLE LIQUIDPROOF BOOTIE (July 9, 1993)

FDA data resources