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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 K953251
Device Name MERTEX-PLUS O.R./SURGEONS GOWN
Applicant
Mercana Industries , Ltd.
95 E. Beaver Creek Rd. Unit
4
Richmond Hill,  CA
Applicant Contact LEN P KLEINE
Correspondent
Mercana Industries , Ltd.
95 E. Beaver Creek Rd. Unit
4
Richmond Hill,  CA
Correspondent Contact LEN P KLEINE
Regulation Number878.4040
Classification Product Code
FYA  
Date Received07/12/1995
Decision Date 09/05/1995
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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