VIVAMED FISTULA NEEDLE
FDA 510(k) clearance K903440 · decided 1992-04-20
Clearance details
- K-number
- K903440
- Device name
- VIVAMED FISTULA NEEDLE
- Applicant
- S.S. Ent.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-31
- Decision date
- 1992-04-20
- Days to decision
- 629 days
- Clearance type
- Traditional
- Product code
- FIE
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Weston, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.