BLUE SUI SLING
FDA 510(k) clearance K121754 · decided 2012-10-10
Clearance details
- K-number
- K121754
- Device name
- BLUE SUI SLING
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2012-06-14
- Decision date
- 2012-10-10
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- OTN
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.