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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 K012240
Device Name MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE
Applicant
Mercan AB
10907 Wareham Court
Austin,  TX  78739
Applicant Contact JEFFREY O STULL
Correspondent
Mercan AB
10907 Wareham Court
Austin,  TX  78739
Correspondent Contact JEFFREY O STULL
Regulation Number878.4040
Classification Product Code
FYA  
Date Received07/17/2001
Decision Date 10/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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