The following data is part of a premarket notification filed by Femcare Ltd. with the FDA for Li Vasectomy.
Device ID | K932465 |
510k Number | K932465 |
Device Name: | LI VASECTOMY |
Classification | Surgical Instruments, G-u, Manual (and Accessories) |
Applicant | FEMCARE LTD. ST. PETER'S ST. NOTTINGHAM Ng7 3en England, GB |
Contact | Andrew Martin |
Correspondent | Andrew Martin FEMCARE LTD. ST. PETER'S ST. NOTTINGHAM Ng7 3en England, GB |
Product Code | KOA |
CFR Regulation Number | 876.4730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-21 |
Decision Date | 1994-03-02 |