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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 K914235
Device Name ASEP SURGEONS GOWN
Applicant
Baxter Interwoven Offsite
2441 Tampa E. Blvd.
Tampa,  FL  33619
Applicant Contact DOUGLAS STANTE
Correspondent
Baxter Interwoven Offsite
2441 Tampa E. Blvd.
Tampa,  FL  33619
Correspondent Contact DOUGLAS STANTE
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/20/1991
Decision Date 04/14/1992
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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