The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Stone Dislodger, Basket.
| Device ID | K970121 |
| 510k Number | K970121 |
| Device Name: | STONE DISLODGER, BASKET |
| Classification | Dislodger, Stone, Flexible |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Contact | Carol J Holloway |
| Correspondent | Carol J Holloway BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Product Code | FGO |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-14 |
| Decision Date | 1997-04-02 |
| Summary: | summary |