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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 K862438
Device Name SURGICAL DRAPES AND DRAPE ACCESSORIES
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 Received06/26/1986
Decision Date 07/16/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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