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510(k) K772060

PROTECT IV GARD by Omnicon Medical Corp. — Product Code FMP

K772060 is an FDA 510(k) premarket notification submitted by Omnicon Medical Corp. for the device "PROTECT IV GARD". The FDA issued a decision of Substantially Equivalent on Dec 20, 1977. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Omnicon Medical Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 20, 1977
Date Received
Oct 31, 1977
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 Omnicon Medical Corp.

  • K823872 — EMERGENCY TRACHEOSTOMY KIT (Jan 21, 1983)
  • K820577 — ANESTHESIA BACTERIA FILTER (Mar 18, 1982)
  • K820576 — MAINFLOW BACTERIA FILTER (Mar 18, 1982)
  • K801804 — ANESTHESIA BACTERIA FILTER (Aug 13, 1980)
  • K801803 — MAINFLOW BACTERIA FILTER (Aug 13, 1980)
  • K770136 — DISPOSABLE BACTERIA FILTER (Feb 14, 1977)
  • K770001 — AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S (Jan 12, 1977)
  • K760819 — CONDUCTIVE ANESTHESIA BREATHING CIRCUIT (Oct 27, 1976)
  • K760149 — CONDUCTIVE ANESTHSIA BREATH. CIRCUIT (Jul 19, 1976)

Other clearances for product code FMP

  • K150243 — Invictus Medical GelShield (May 1, 2015)
  • K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING (Jul 31, 1995)
  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (Mar 28, 1994)
  • K820584 — DECUBICARE PADS & ACCESSORIES (Mar 25, 1982)
  • K812344 — HEEL OR ELBOW PROTECTOR (Sep 11, 1981)
  • K811184 — SPENCO DERMAL PADS (May 20, 1981)
  • K802829 — SCANLAN VASCU-STATT (Jan 15, 1981)
  • K802185 — ARTERIAL BLOOD SAMPLING KIT (Oct 10, 1980)
  • K801694 — FLOTATION PAD FOR OPERATING TABLE (Aug 27, 1980)
  • K801195 — DERMALEX OR NATRAWOOL SKIN PRESSURE PROT (Jun 9, 1980)

FDA data resources