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510(k) K901922

Device
SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536
Applicant
SAFTE S.P.A.
510(k) number
K901922
Product code
EXN  
Decision
Substantially Equivalent (SESE)
Decision date
1990-10-26
Date received
1990-04-30
Regulation
876.5970
Classification name
Support, Hernia
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ZANELLA
Address
Via Trecate, 9/A 10141 Torino Italia IT

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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