The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt Halo System.
| Device ID | K090733 |
| 510k Number | K090733 |
| Device Name: | PMT HALO SYSTEM |
| Classification | Tong, Skull For Traction |
| Applicant | PMT CORP. 1500 PARK RD. P.O. OX 610 Chanhassen, MN 55317 |
| Contact | Eric Caille |
| Correspondent | Eric Caille PMT CORP. 1500 PARK RD. P.O. OX 610 Chanhassen, MN 55317 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-19 |
| Decision Date | 2009-07-28 |
| Summary: | summary |