PELVIC FLOOR REPAIR SYSTEM
FDA 510(k) clearance K091131 · decided 2009-05-08
Clearance details
- K-number
- K091131
- Device name
- PELVIC FLOOR REPAIR SYSTEM
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2009-04-20
- Decision date
- 2009-05-08
- Days to decision
- 18 days
- Clearance type
- Abbreviated
- Product code
- OTP
- Device class
- 3
- Regulation number
- 884.5980
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.