Device Classification Name |
equipment, traction, powered
|
510(k) Number |
K073132 |
Device Name |
MODEL D DISC FORCE |
Applicant |
NORTH AMERICAN MEDICAL CORP (NAM) |
1649 SANDS PLACE S.E. |
SUITE A |
MARIETTA,
GA
30067
|
|
Applicant Contact |
CHELLO GRACE |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 890.5900
|
Classification Product Code |
|
Date Received | 11/07/2007 |
Decision Date | 04/03/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|