LEECH, MEDICINAL
FDA 510(k) clearance K140907 · decided 2015-08-07
Clearance details
- K-number
- K140907
- Device name
- LEECH, MEDICINAL
- Applicant
- Carolina Biological Supply Co.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-08
- Decision date
- 2015-08-07
- Days to decision
- 486 days
- Clearance type
- Traditional
- Product code
- NRN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Burlington, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDICINAL LEECHES (K132958) | Biopharm (Uk) , Ltd. | 2014-02-19 |
| MEDICINAL LEECHES (K040187) | Ricarimpex Sas | 2004-06-21 |
Recalls involving this device
No recalls on record reference this clearance.