The following data is part of a premarket notification filed by Domain Surgical, Inc. with the FDA for Laparoscopic Fmsealer.
| Device ID | K142229 |
| 510k Number | K142229 |
| Device Name: | Laparoscopic FMsealer |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DOMAIN SURGICAL, INC. 1370 SOUTH 2100 EAST Salt Lake City, UT 84108 |
| Contact | Curtis Jensen |
| Correspondent | Curtis Jensen DOMAIN SURGICAL, INC. 1370 SOUTH 2100 EAST Salt Lake City, UT 84108 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-13 |
| Decision Date | 2015-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20859729006169 | K142229 | 000 |