Cleared Traditional

K772060 - PROTECT IV GARD
(FDA 510(k) Clearance)

K772060 · Omnicon Medical Corp. · General Hospital
Dec 1977
Decision
50d
Days
Class 1
Risk

K772060 is an FDA 510(k) clearance for the PROTECT IV GARD. This device is classified as a Protector, Skin Pressure (Class I — General Controls, product code FMP).

Submitted by Omnicon Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1977, 50 days after receiving the submission on October 31, 1977.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6450.

Submission Details

510(k) Number K772060 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1977
Decision Date December 20, 1977
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FMP — Protector, Skin Pressure
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6450