FALLER STYLET
FDA 510(k) clearance K130441 · decided 2013-04-19
Clearance details
- K-number
- K130441
- Device name
- FALLER STYLET
- Applicant
- Medionics International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-02-21
- Decision date
- 2013-04-19
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- FJS
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Markham, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.