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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 K891677
Device Name COATED ISOLATION GOWN
Applicant
DURANTE INTL., INC.
1233 WEST LOOP SOUTH - SUITE
1020
HOUSTON,  TX  77027
Applicant Contact EVELYN MCALLISTER
Correspondent
DURANTE INTL., INC.
1233 WEST LOOP SOUTH - SUITE
1020
HOUSTON,  TX  77027
Correspondent Contact EVELYN MCALLISTER
Regulation Number878.4040
Classification Product Code
FYC  
Date Received03/21/1989
Decision Date 04/20/1989
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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