The following data is part of a premarket notification filed by Annex Medical, Inc. with the FDA for Flexible Snare.
Device ID | K902265 |
510k Number | K902265 |
Device Name: | FLEXIBLE SNARE |
Classification | Snare, Flexible |
Applicant | ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie, MN 55344 |
Contact | Stuart J Lind |
Correspondent | Stuart J Lind ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie, MN 55344 |
Product Code | FDI |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-21 |
Decision Date | 1990-07-27 |