The following data is part of a premarket notification filed by Med-tek Corp. with the FDA for L.m.s. Self-detachable Broach With Stop.
| Device ID | K901273 |
| 510k Number | K901273 |
| Device Name: | L.M.S. SELF-DETACHABLE BROACH WITH STOP |
| Classification | Pin, Fixation, Smooth |
| Applicant | MED-TEK CORP. 6535 E. 82ND ST. SUITE 215 Indianapolis, IN 46250 |
| Contact | Kenneth Epling |
| Correspondent | Kenneth Epling MED-TEK CORP. 6535 E. 82ND ST. SUITE 215 Indianapolis, IN 46250 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-19 |
| Decision Date | 1990-06-05 |