The following data is part of a premarket notification filed by Domain Surgical, Inc. with the FDA for Fmwand Handpiece Se.
| Device ID | K140384 |
| 510k Number | K140384 |
| Device Name: | FMWAND HANDPIECE SE |
| 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 | 2014-02-14 |
| Decision Date | 2014-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20859729006176 | K140384 | 000 |
| 20859729006145 | K140384 | 000 |
| 20859729006138 | K140384 | 000 |
| 20859729006121 | K140384 | 000 |
| 20859729006114 | K140384 | 000 |
| 20859729006107 | K140384 | 000 |