BACKSTOP AND BACKSTOP INJECTOR
FDA 510(k) clearance K090430 · decided 2009-06-02
Clearance details
- K-number
- K090430
- Device name
- BACKSTOP AND BACKSTOP INJECTOR
- Applicant
- Pluromed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-02-19
- Decision date
- 2009-06-02
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- ONJ
- Device class
- 2
- Regulation number
- 876.4680
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.