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510(k) K901922

SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 by Safte S.P.A. — Product Code EXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
April 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Support, Hernia
Device Class
Class I
Regulation Number
876.5970
Review Panel
GU
Submission Type