The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Tmp Mandibular Compression System.
Device ID | K905024 |
510k Number | K905024 |
Device Name: | TMP MANDIBULAR COMPRESSION SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
Contact | Jeffrey Cheek |
Correspondent | Jeffrey Cheek TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-07 |
Decision Date | 1991-06-24 |