The following data is part of a premarket notification filed by Halt Medical Inc with the FDA for Acessa Guidance Handpiece.
| Device ID | K132184 |
| 510k Number | K132184 |
| Device Name: | ACESSA GUIDANCE HANDPIECE |
| Classification | Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Applicant | HALT MEDICAL INC 131 SAND CREEK RD STE., B Brentwood, CA 94513 |
| Contact | Clarisa Tate |
| Correspondent | Clarisa Tate HALT MEDICAL INC 131 SAND CREEK RD STE., 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 | 2013-07-15 |
| Decision Date | 2014-04-28 |
| Summary: | summary |