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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 K924101
Device Name STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
Applicant
BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
mcgaw pk,  IL  60085
Applicant Contact thomas j moutvic
Correspondent
BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
mcgaw pk,  IL  60085
Correspondent Contact thomas j moutvic
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/13/1992
Decision Date 04/11/1994
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
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