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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K844196
Device Name WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
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
Regulation Number880.6060
Classification Product Code
KME  
Date Received10/30/1984
Decision Date 12/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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