Device Classification Name |
Equipment, Traction, Powered
|
510(k) Number |
K101889 |
Device Name |
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE |
Applicant |
PIVOTAL HEALTH SOLUTIONS |
1521 9TH AVE SE STE 3 |
WATERTOWN,
SD
57201 -3998
|
|
Applicant Contact |
PHILLIP KLEIN |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
WILLIAM SAMMONS |
Regulation Number | 890.5900
|
Classification Product Code |
|
Date Received | 07/07/2010 |
Decision Date | 08/27/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|