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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Support, Hernia
510(k) Number K901922
Device Name SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536
Applicant
Safte S.P.A.
Via Trecate, 9/A
10141 Torino
Italia,  IT
Applicant Contact ZANELLA
Correspondent
Safte S.P.A.
Via Trecate, 9/A
10141 Torino
Italia,  IT
Correspondent Contact ZANELLA
Regulation Number876.5970
Classification Product Code
EXN  
Date Received04/30/1990
Decision Date 10/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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