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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 K971920
Device Name GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
Applicant
Customed, Inc.
Calle Igualdad #7
Fajardo,  PR  00738
Applicant Contact GLADYNELL RODRIQUEZ
Correspondent
Customed, Inc.
Calle Igualdad #7
Fajardo,  PR  00738
Correspondent Contact GLADYNELL RODRIQUEZ
Regulation Number878.4040
Classification Product Code
FYA  
Date Received05/23/1997
Decision Date 12/04/1997
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
Recalls CDRH Recalls
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