The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Techmedica Heavyd Gauge Titanium Mesh Sheet/strips.
| Device ID | K873005 |
| 510k Number | K873005 |
| Device Name: | TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS |
| Classification | Plate, Fixation, Bone |
| Applicant | TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
| Contact | Charles M Raggio |
| Correspondent | Charles M Raggio TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-04 |
| Decision Date | 1987-09-01 |