The following data is part of a premarket notification filed by Biopharm (uk) Ltd. with the FDA for Medicinal Leeches.
| Device ID | K132958 |
| 510k Number | K132958 |
| Device Name: | MEDICINAL LEECHES |
| Classification | Leeches, Medicinal |
| Applicant | BIOPHARM (UK) LTD. 2 BRYNGWILI ROAD Hendy, GB Sa4 0xt |
| Contact | Bethany Sawyer |
| Correspondent | Bethany Sawyer BIOPHARM (UK) LTD. 2 BRYNGWILI ROAD Hendy, GB Sa4 0xt |
| Product Code | NRN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-20 |
| Decision Date | 2014-02-19 |
| Summary: | summary |