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510(k) K790995

CONTEX by Foam Tek, Inc. — Product Code FMP

K790995 is an FDA 510(k) premarket notification submitted by Foam Tek, Inc. for the device "CONTEX". The FDA issued a decision of Substantially Equivalent on June 11, 1979. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1979
Date Received
May 29, 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 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