Home / 510(k) Clearances / K934731

510(k) K934731

MEDSURG STERILE IMAGING PRODUCTS by Medsurg Industries, Inc. — Product Code FMP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1994
Date Received
September 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Skin Pressure
Device Class
Class I
Regulation Number
880.6450
Review Panel
HO
Submission Type

Other clearances by Medsurg Industries, Inc.

  • K920780 — MEDSURG INSERTION TRAY (August 19, 1994)
  • K940175 — MEDSURG STERILE O.R. TOWELS (May 26, 1994)
  • K925558 — INFILTUBE (March 4, 1994)
  • K934971 — STERILE LAPAROTOMY SPONGES (February 7, 1994)
  • K920421 — MEDSURG MARSHMALLOW TRAY (December 13, 1993)
  • K920838 — MEDSURG CIRCUMCISION TRAY (October 15, 1993)
  • K931932 — DRESSING CHANGE TRAY-MODIFIED (August 27, 1993)
  • K914037 — MEDSURG O.R. PROCEDURE TRAY (June 22, 1993)
  • K914036 — MEDSURG LAPAROSCOPY TRAY (March 18, 1992)
  • K893938 — CONTINUOUS EPIDURAL ANESTHESIA TRAY (August 7, 1989)

Other clearances for product code FMP

  • K150243 — Invictus Medical GelShield (May 1, 2015)
  • K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING (July 31, 1995)
  • K820584 — DECUBICARE PADS & ACCESSORIES (March 25, 1982)
  • K812344 — HEEL OR ELBOW PROTECTOR (September 11, 1981)
  • K811184 — SPENCO DERMAL PADS (May 20, 1981)
  • K802829 — SCANLAN VASCU-STATT (January 15, 1981)
  • K802185 — ARTERIAL BLOOD SAMPLING KIT (October 10, 1980)
  • K801694 — FLOTATION PAD FOR OPERATING TABLE (August 27, 1980)
  • K801195 — DERMALEX OR NATRAWOOL SKIN PRESSURE PROT (June 9, 1980)
  • K792297 — SPAN AIDS KIT (December 20, 1979)