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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K851853
Device Name STERILE GOWNS, MASKS & TOWELS
Applicant
Biological & Environmental Control Laboratories
615 Front St.
Toledo,  OH  43605
Applicant Contact NORMAN HUFF
Correspondent
Biological & Environmental Control Laboratories
615 Front St.
Toledo,  OH  43605
Correspondent Contact NORMAN HUFF
Date Received04/26/1985
Decision Date 05/16/1985
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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