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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863637
Device Name UPDATED STERILE GOWNS, MASKS AND TOWELS
Applicant
Biological & Environmental Control Laboratories
615 Front St.
Toledo,  OH  43605
Applicant Contact NORMAN J HUFF
Correspondent
Biological & Environmental Control Laboratories
615 Front St.
Toledo,  OH  43605
Correspondent Contact NORMAN J HUFF
Date Received09/17/1986
Decision Date 09/29/1986
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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