The following data is part of a premarket notification filed by Annex Medical, Inc. with the FDA for Metal Ureteral Basket Stone Dislodger.
| Device ID | K951532 |
| 510k Number | K951532 |
| Device Name: | METAL URETERAL BASKET STONE DISLODGER |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | ANNEX MEDICAL, INC. 7098 SHADY OAK RD. Eden Prairie, MN 55344 |
| Contact | Eugene C Karels |
| Correspondent | Eugene C Karels ANNEX MEDICAL, INC. 7098 SHADY OAK RD. Eden Prairie, MN 55344 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-03 |
| Decision Date | 1995-07-19 |