The following data is part of a premarket notification filed by Surgovations Llc with the FDA for Surgeobite.
| Device ID | K172978 |
| 510k Number | K172978 |
| Device Name: | SurgeoBite |
| Classification | Block, Bite |
| Applicant | Surgovations LLC 110 Fairway Run Forsyth, GA 31029 |
| Contact | Chris Menard |
| Correspondent | Julie Stephens Regulatory Resources Group, Inc. 111 Laurel Ridge Dr Alpharetta, GA 30004 |
| Product Code | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2017-12-22 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SURGEOBITE 86384963 5082679 Live/Registered |
Surgovations, LLC 2014-09-04 |