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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 K842989
Device Name SHAVE PREP KITS
Applicant
Biological & Environmental Control Laboratories
615 Front St.
Toledo,  OH  43605
Applicant Contact JAMES P KULLA
Correspondent
Biological & Environmental Control Laboratories
615 Front St.
Toledo,  OH  43605
Correspondent Contact JAMES P KULLA
Regulation Number880.6060
Classification Product Code
KME  
Date Received07/30/1984
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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