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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 K931267
Device Name CONVERTORS ISO BAC DRAPE MATERIAL
Applicant
Baxter Healthcare Corp
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact SHARON RICHTER
Correspondent
Baxter Healthcare Corp
1500 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact SHARON RICHTER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/08/1993
Decision Date 11/07/1994
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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