The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Hatcher Stone Extractor - Disposable Catheter.
| Device ID | K862949 |
| 510k Number | K862949 |
| Device Name: | HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER |
| Classification | Dislodger, Stone, Biliary |
| Applicant | OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor, FL 33563 |
| Contact | James A Cormack |
| Correspondent | James A Cormack OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor, FL 33563 |
| Product Code | LQR |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-05 |
| Decision Date | 1986-10-31 |