The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace Cervical Traction Halozs, Tongs & Pins.
| Device ID | K954069 |
| 510k Number | K954069 |
| Device Name: | ACE CERVICAL TRACTION HALOZS, TONGS & PINS |
| Classification | Tong, Skull For Traction |
| Applicant | ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles, CA 90245 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles, CA 90245 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-30 |
| Decision Date | 1995-10-12 |