The following data is part of a premarket notification filed by Carolina Biological Supply Co. with the FDA for Leech, Medicinal.
Device ID | K140907 |
510k Number | K140907 |
Device Name: | LEECH, MEDICINAL |
Classification | Leeches, Medicinal |
Applicant | CAROLINA BIOLOGICAL SUPPLY CO. 2700 YORK RD. Burlington, NC 27215 |
Contact | Keith E Barker |
Correspondent | Keith E Barker CAROLINA BIOLOGICAL SUPPLY CO. 2700 YORK RD. Burlington, NC 27215 |
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 | 2014-04-08 |
Decision Date | 2015-08-07 |
Summary: | summary |