Device Classification Name |
equipment, traction, powered
|
510(k) Number |
K031862 |
Device Name |
SPINERX-LDM |
Applicant |
SPINERX TECHNOLOGY |
6100 BRITTMOORE RD |
BLDG S |
HOUSTON,
TX
77041
|
|
Applicant Contact |
HUGHIE WATSON |
Correspondent |
SPINERX TECHNOLOGY |
6100 BRITTMOORE RD |
BLDG S |
HOUSTON,
TX
77041
|
|
Correspondent Contact |
HUGHIE WATSON |
Regulation Number | 890.5900
|
Classification Product Code |
|
Date Received | 06/16/2003 |
Decision Date | 10/31/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|