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510(k) K791709

HEEL/ELBOW PROTECTORS by Fibre Formations, Inc. — Product Code FMP

K791709 is an FDA 510(k) premarket notification submitted by Fibre Formations, Inc. for the device "HEEL/ELBOW PROTECTORS". The FDA issued a decision of Substantially Equivalent on September 24, 1979. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Fibre Formations, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1979
Date Received
August 27, 1979
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.

  • K790922 — DISPOSABLE ADULT DIAPER (July 30, 1979)
  • K781930 — PANT LINER, DISP. INCONTINENT (February 1, 1979)
  • K781233 — IV ARMBOARDS (August 14, 1978)
  • K781246 — FOAM COMFORT RINGS (August 10, 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)

FDA data resources