Cleared Traditional

MATTRESSES, CONDUCTIVE & COVERS

K780033 · Chase Mfg. Co. · General Hospital
Feb 1978
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K780033 is an FDA 510(k) clearance for the MATTRESSES, CONDUCTIVE & COVERS, a Cover, Mattress (medical Purposes) (Class I — General Controls, product code FMW), submitted by Chase Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1978, 43 days after receiving the submission on January 9, 1978. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6190.

Submission Details

510(k) Number K780033 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 1978
Decision Date February 21, 1978
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FMW — Cover, Mattress (medical Purposes)
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6190

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