The following data is part of a premarket notification filed by Hand Biomechanics Lab, Inc. with the FDA for Digit Widget.
Device ID | K992970 |
510k Number | K992970 |
Device Name: | DIGIT WIDGET |
Classification | Pin, Fixation, Threaded |
Applicant | HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 Sacramento, CA 95825 |
Contact | John M Agee |
Correspondent | John M Agee HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 Sacramento, CA 95825 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-09-03 |
Decision Date | 1999-11-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00861994000212 | K992970 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIGIT WIDGET 86187416 4636036 Live/Registered |
John M. Agee 2014-02-07 |
DIGIT WIDGET 85376032 4138043 Dead/Cancelled |
Siek, Jason Louis 2011-07-20 |