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 |