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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K870123
Device Name SURGICAL DRAPES AND ACCESSORIES USING PCCE FILM
Applicant
Avery Intl.
Fasson Medical Products
7100 Lindsay Dr.
Mentor,  OH  44060
Applicant Contact HOWARD T COOPER
Correspondent
Avery Intl.
Fasson Medical Products
7100 Lindsay Dr.
Mentor,  OH  44060
Correspondent Contact HOWARD T COOPER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/12/1987
Decision Date 02/04/1987
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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