MODIFICATION TO SURGICAL MESH POLYMERIC
FDA 510(k) clearance K040787 · decided 2004-04-14
Clearance details
- K-number
- K040787
- Device name
- MODIFICATION TO SURGICAL MESH POLYMERIC
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2004-03-29
- Decision date
- 2004-04-14
- Days to decision
- 16 days
- Clearance type
- Special
- Product code
- OTN
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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.