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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K921058
Device Name DISPOSABLE ISOLATION GOWN
Applicant
Nat'L Surtex Corp.
359 Mclean Blvd.
Paterson,  NJ  07513
Applicant Contact DICKSON HEE
Correspondent
Nat'L Surtex Corp.
359 Mclean Blvd.
Paterson,  NJ  07513
Correspondent Contact DICKSON HEE
Regulation Number878.4040
Classification Product Code
FYC  
Date Received03/05/1992
Decision Date 08/11/1992
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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