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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bandage, Cast
510(k) Number K831492
Device Name YESONA PLASTER OF PARIS BANDAGE
Applicant
Watson Phillips Y Cia. Sucs., S.A. DE C.V.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Watson Phillips Y Cia. Sucs., S.A. DE C.V.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3025
Classification Product Code
ITG  
Date Received05/10/1983
Decision Date 06/30/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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