The following data is part of a premarket notification filed by Curvebeam, Llc with the FDA for In Reach.
Device ID | K170789 |
510k Number | K170789 |
Device Name: | In Reach |
Classification | System, X-ray, Tomography, Computed |
Applicant | CurveBeam, LLC 175 Titus Ave Suite 300 Warrington, PA 18976 |
Contact | Stuti Singh |
Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2017-03-16 |
Decision Date | 2017-05-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00863152000331 | K170789 | 000 |
00863152000324 | K170789 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IN REACH 86216091 4757074 Live/Registered |
CurveBeam, LLC 2014-03-10 |
IN REACH 77046448 not registered Dead/Abandoned |
Blue Cross and Blue Shield Association 2006-11-17 |
IN REACH 75150756 not registered Dead/Abandoned |
Secure Technologies, Inc. 1996-07-29 |