Cleared Traditional

ADAMCO DUST COVER

K791513 · Chase Mfg. Co. · General Hospital
Oct 1979
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K791513 is an FDA 510(k) clearance for the ADAMCO DUST COVER, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Chase Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on October 11, 1979, 76 days after receiving the submission on July 27, 1979. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K791513 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1979
Decision Date October 11, 1979
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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