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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 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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