The following data is part of a premarket notification filed by Annex Medical, Inc. with the FDA for Biliary Stone Dislodger.
| Device ID | K925559 |
| 510k Number | K925559 |
| Device Name: | BILIARY STONE DISLODGER |
| Classification | Dislodger, Stone, Biliary |
| 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 | LQR |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-03 |
| Decision Date | 1992-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B032500240 | K925559 | 000 |
| 24026704418880 | K925559 | 000 |