Device Classification Name |
Equipment, Traction, Powered
|
510(k) Number |
K051013 |
Device Name |
SPINEMED S200B/S200C |
Applicant |
CERT HEALTH SCIENCES, LLC |
10440 LITTLE PATUXENT PARKWAY |
SUITE 300 |
COLUMBIA,
MD
21044
|
|
Applicant Contact |
TIM R EMSKY |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
TAMAS BORSAI |
Regulation Number | 890.5900
|
Classification Product Code |
|
Date Received | 04/21/2005 |
Decision Date | 04/27/2005 |
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
|
|
|