SENTREX BIOSPONGE MPD
FDA 510(k) clearance K123961 · decided 2013-04-05
Clearance details
- K-number
- K123961
- Device name
- SENTREX BIOSPONGE MPD
- Applicant
- Bionova Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-26
- Decision date
- 2013-04-05
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Germantown, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.