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 |