The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace Universal Tong.
| Device ID | K842680 |
| 510k Number | K842680 |
| Device Name: | ACE UNIVERSAL TONG |
| Classification | Tong, Skull For Traction |
| Applicant | BUCKMAN CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-10 |
| Decision Date | 1984-09-04 |