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510(k) K952897

NIOMED SHOE COVERS by Amerasia Corp. — Product Code FXP

K952897 is an FDA 510(k) premarket notification submitted by Amerasia Corp. for the device "NIOMED SHOE COVERS". The FDA issued a decision of Substantially Equivalent on October 23, 1995. The device falls under product code FXP (Cover, Shoe, Operating-Room), a Class I device regulated under 21 CFR 878.4040. Amerasia Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1995
Date Received
June 23, 1995
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 Amerasia Corp.

  • K955833 — NIOMED SURGICAL CAPS (March 15, 1996)
  • K954747 — NIOMED BARRIER GOWNS (March 6, 1996)
  • K954454 — NIOMED SURGICAL HOOD (January 23, 1996)
  • K954455 — NIOMED BOUFFANT CAPS (January 23, 1996)
  • K952937 — NIOMED NON-SKID SHOE COVERS (October 23, 1995)

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)
  • 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