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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 K940702
Device Name CONVERTORS OPTI-SORB DRAPE MATERIAL
Applicant
BAXTER HEALTHCARE CORP.
1425 LAKE COOK RD.
LC1-3
DEERFIELD,  IL  60015
Applicant Contact SHARON RICHTER
Correspondent
BAXTER HEALTHCARE CORP.
1425 LAKE COOK RD.
LC1-3
DEERFIELD,  IL  60015
Correspondent Contact SHARON RICHTER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/16/1994
Decision Date 04/26/1994
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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