The following data is part of a premarket notification filed by Halt Medical Inc. with the FDA for The Ablation System.
| Device ID | K121858 |
| 510k Number | K121858 |
| Device Name: | THE ABLATION SYSTEM |
| Classification | Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Applicant | HALT MEDICAL INC. 131 Sand Creek Road, Suite B Brentwood, CA 94513 |
| Contact | Clarisa Tate |
| Correspondent | Clarisa Tate HALT MEDICAL INC. 131 Sand Creek Road, Suite B Brentwood, CA 94513 |
| Product Code | HFG |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-26 |
| Decision Date | 2012-11-05 |
| Summary: | summary |