The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Pmt-halo/orthopedic Jacket System.
| Device ID | K834047 |
| 510k Number | K834047 |
| Device Name: | PMT-HALO/ORTHOPEDIC JACKET SYSTEM |
| Classification | Tong, Skull For Traction |
| Applicant | PROGRESS MANKIND TECHNOLOGY BOX 464 Hopkins, MN 55343 |
| Contact | Alfred A Iversen |
| Correspondent | Alfred A Iversen PROGRESS MANKIND TECHNOLOGY BOX 464 Hopkins, MN 55343 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-23 |
| Decision Date | 1984-02-17 |