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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 K911508
Device Name MAGNA SURGEONS GOWNS
Applicant
Dms Miami, Inc.
P.O. Box 4217
Vega Baja, Puerto Rico 00764
Vega Baja,  GW
Applicant Contact JESSE H GONZALEZ
Correspondent
Dms Miami, Inc.
P.O. Box 4217
Vega Baja, Puerto Rico 00764
Vega Baja,  GW
Correspondent Contact JESSE H GONZALEZ
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/03/1991
Decision Date 06/17/1991
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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