The following data is part of a premarket notification filed by Ace Orthopedic Manufacturing Co. with the FDA for Trippi-wells Dual Purpose Universal Tong.
| Device ID | K810193 |
| 510k Number | K810193 |
| Device Name: | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG |
| Classification | Tong, Skull For Traction |
| Applicant | ACE ORTHOPEDIC MANUFACTURING CO. 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 | 1981-01-23 |
| Decision Date | 1981-03-20 |