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 Number | 876.5970
|
Classification Product Code |
|
Date Received | 04/30/1990 |
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
|
|
|