The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Hatcher Stone-embolis Extractor.
| Device ID | K931115 |
| 510k Number | K931115 |
| Device Name: | HATCHER STONE-EMBOLIS EXTRACTOR |
| Classification | Dislodger, Stone, Biliary |
| Applicant | IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Lorna K Linville |
| Correspondent | Lorna K Linville IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | LQR |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-04 |
| Decision Date | 1993-08-20 |