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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
510(k) Number K913506
Device Name CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
Applicant
BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
MCGAW PK,  IL  60085
Applicant Contact HENRY BODNER
Correspondent
BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
MCGAW PK,  IL  60085
Correspondent Contact HENRY BODNER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/07/1991
Decision Date 10/11/1991
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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