The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Cypress Cervical Traction Equipment, Cypress Halo.
| Device ID | K894959 |
| 510k Number | K894959 |
| Device Name: | CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO |
| Classification | Component, Traction, Invasive |
| Applicant | ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Contact | Denis Stednitz |
| Correspondent | Denis Stednitz ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-07 |
| Decision Date | 1990-09-14 |