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510(k) K781246

FOAM COMFORT RINGS by Fibre Formations, Inc. — Product Code FMP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1978
Date Received
July 21, 1978
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 Fibre Formations, Inc.

  • K791709 — HEEL/ELBOW PROTECTORS (September 24, 1979)
  • K790922 — DISPOSABLE ADULT DIAPER (July 30, 1979)
  • K781930 — PANT LINER, DISP. INCONTINENT (February 1, 1979)
  • K781233 — IV ARMBOARDS (August 14, 1978)

Other clearances for product code FMP

  • K150243 — Invictus Medical GelShield (May 1, 2015)
  • K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING (July 31, 1995)
  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (March 28, 1994)
  • 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)