The following data is part of a premarket notification filed by North American Medical Corp (nam) with the FDA for Model D Disc Force.
| Device ID | K073132 |
| 510k Number | K073132 |
| Device Name: | MODEL D DISC FORCE |
| Classification | Equipment, Traction, Powered |
| Applicant | NORTH AMERICAN MEDICAL CORP (NAM) 1649 SANDS PLACE S.E. SUITE A Marietta, GA 30067 |
| Contact | Chello Grace |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-07 |
| Decision Date | 2008-04-03 |
| Summary: | summary |