Cleared Traditional

COMFICARE PAD (FOR SINGEL PT USE)

K792001 · Hamilton Industries, Inc. · General Hospital
Oct 1979
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K792001 is an FDA 510(k) clearance for the COMFICARE PAD (FOR SINGEL PT USE), a Mattress, Air Flotation, Alternating Pressure (Class II — Special Controls, product code FNM), submitted by Hamilton Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1979, 21 days after receiving the submission on October 5, 1979. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K792001 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1979
Decision Date October 26, 1979
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FNM — Mattress, Air Flotation, Alternating Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5550