The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Techmedica I.b.o. Blade.
| Device ID | K883922 |
| 510k Number | K883922 |
| Device Name: | TECHMEDICA I.B.O. BLADE |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
| Contact | Rick A Buss |
| Correspondent | Rick A Buss TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-16 |
| Decision Date | 1988-12-08 |