BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
FDA 510(k) clearance K131496 · decided 2013-07-10
Clearance details
- K-number
- K131496
- Device name
- BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
- Applicant
- Bsn Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-23
- Decision date
- 2013-07-10
- Days to decision
- 48 days
- Clearance type
- Special
- Product code
- DWL
- Device class
- 2
- Regulation number
- 880.5780
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rutherford College, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.