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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 K853347
Device Name MAI STERILE UTILITY DRAPE
Applicant
Medical Assoc. Intl., Inc.
P.O. Box 123
501 Gage Blvd.
Topeka,  KS  66601
Applicant Contact ROBERT BANKS
Correspondent
Medical Assoc. Intl., Inc.
P.O. Box 123
501 Gage Blvd.
Topeka,  KS  66601
Correspondent Contact ROBERT BANKS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/12/1985
Decision Date 09/05/1985
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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