The following data is part of a premarket notification filed by Domain Surgical, Inc. with the FDA for Domain Surgical System.
| Device ID | K110439 |
| 510k Number | K110439 |
| Device Name: | DOMAIN SURGICAL SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DOMAIN SURGICAL, INC. 1370 SOUTH 2100 EAST Salt Lake Sity, UT 84108 |
| Contact | Curtis Jensen |
| Correspondent | Curtis Jensen DOMAIN SURGICAL, INC. 1370 SOUTH 2100 EAST Salt Lake Sity, 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 | 2011-02-15 |
| Decision Date | 2011-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859729006035 | K110439 | 000 |
| 00859729006004 | K110439 | 000 |