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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 December 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
December 20, 1977
Date Received
October 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 (January 21, 1983)
  • K820577 — ANESTHESIA BACTERIA FILTER (March 18, 1982)
  • K820576 — MAINFLOW BACTERIA FILTER (March 18, 1982)
  • K801804 — ANESTHESIA BACTERIA FILTER (August 13, 1980)
  • K801803 — MAINFLOW BACTERIA FILTER (August 13, 1980)
  • K770136 — DISPOSABLE BACTERIA FILTER (February 14, 1977)
  • K770001 — AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S (January 12, 1977)
  • K760819 — CONDUCTIVE ANESTHESIA BREATHING CIRCUIT (October 27, 1976)
  • K760149 — CONDUCTIVE ANESTHSIA BREATH. CIRCUIT (July 19, 1976)

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