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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K944138
Device Name INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL
Applicant
Baxter Healthcare Corp
1300 Waukegan Rd. Bldg. J
Mcgaw Park,  IL  60085
Applicant Contact ELIZABETH C DUDLEY
Correspondent
Baxter Healthcare Corp
1300 Waukegan Rd. Bldg. J
Mcgaw Park,  IL  60085
Correspondent Contact ELIZABETH C DUDLEY
Regulation Number878.4040
Classification Product Code
FYA  
Date Received08/24/1994
Decision Date 12/20/1994
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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