SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536
FDA 510(k) clearance K901922 · decided 1990-10-26
Clearance details
- K-number
- K901922
- Device name
- SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536
- Applicant
- Safte S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-30
- Decision date
- 1990-10-26
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- EXN
- Device class
- 1
- Regulation number
- 876.5970
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Italia, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.