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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K813078
Device Name CONTURA DISPOS. SURG. FACE MASK
Applicant
American Convertors Div., American Pharmaseal
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Convertors Div., American Pharmaseal
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/02/1981
Decision Date 12/18/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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