The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Apex Universal Drive System.
| Device ID | K944476 |
| 510k Number | K944476 |
| Device Name: | APEX UNIVERSAL DRIVE SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
| Contact | Carol A Weideman |
| Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-12 |
| Decision Date | 1994-11-18 |