MOERAE SURGICAL MARKING PEN
FDA 510(k) clearance DEN130004 · decided 2014-12-18
Clearance details
- K-number
- DEN130004
- Device name
- MOERAE SURGICAL MARKING PEN
- Applicant
- Moerae Matrix, Inc.
- Decision
- Unknown
- Date received
- 2013-05-06
- Decision date
- 2014-12-18
- Days to decision
- 591 days
- Clearance type
- Post-NSE
- Product code
- PDW
- Device class
- 2
- Regulation number
- 878.4670
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- North Brunswick, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Cianna Medical SAVI Scout Reflector and SAVI Scout System (K161507) | Cianna Medical, Inc. | 2016-07-29 |
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Recalls involving this device
No recalls on record reference this clearance.