The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Modification Techmedica Mp (miniplating) System.
Device ID | K921801 |
510k Number | K921801 |
Device Name: | MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM |
Classification | Plate, Bone |
Applicant | TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
Contact | Dave Samson |
Correspondent | Dave Samson TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-13 |
Decision Date | 1992-07-15 |