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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Shoe, Operating-Room
510(k) Number K800528
Device Name SHIELD PERFECT FIT; DURA-FIT, DISPOS.
Applicant
American Convertors Div., American Pharmaseal
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Convertors Div., American Pharmaseal
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4040
Classification Product Code
FXP  
Date Received03/07/1980
Decision Date 04/16/1980
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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