Device Classification Name |
manipulator, plunger-like joint
|
510(k) Number |
K946258 |
Device Name |
MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT |
Applicant |
SPINALIGHT, INC. |
320-A BELL PARK DR. |
WOODSTOCK,
GA
30188 -1661
|
|
Applicant Contact |
T A COX |
Correspondent |
SPINALIGHT, INC. |
320-A BELL PARK DR. |
WOODSTOCK,
GA
30188 -1661
|
|
Correspondent Contact |
T A COX |
Classification Product Code |
|
Date Received | 12/06/1994 |
Decision Date | 11/20/1995 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|