The following data is part of a premarket notification filed by Intramed Laboratories, Inc. with the FDA for Endoscopic Retrieval Basket.
| Device ID | K922114 |
| 510k Number | K922114 |
| Device Name: | ENDOSCOPIC RETRIEVAL BASKET |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Contact | Stephen A Sosnowski |
| Correspondent | Stephen A Sosnowski INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-05 |
| Decision Date | 1992-08-03 |