The following data is part of a premarket notification filed by Dvo Extremity Solutions, Llc with the FDA for Volar Plate System.
Device ID | K052150 |
510k Number | K052150 |
Device Name: | VOLAR PLATE SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | DVO EXTREMITY SOLUTIONS, LLC P.O. BOX 205 Derby, CT 06418 |
Contact | Dina L Weissman |
Correspondent | Dina L Weissman DVO EXTREMITY SOLUTIONS, LLC P.O. BOX 205 Derby, CT 06418 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-08-08 |
Decision Date | 2005-09-08 |
Summary: | summary |