Device Classification Name |
Tong, Skull For Traction
|
510(k) Number |
K023959 |
Device Name |
JEROME GLASS RING |
Applicant |
THE JEROME GROUP, INC. |
305 HARPER DR. |
MOORESTOWN,
NJ
08057
|
|
Applicant Contact |
BERNIE TATRO |
Correspondent |
THE JEROME GROUP, INC. |
305 HARPER DR. |
MOORESTOWN,
NJ
08057
|
|
Correspondent Contact |
BERNIE TATRO |
Regulation Number | 882.5960
|
Classification Product Code |
|
Date Received | 11/27/2002 |
Decision Date | 02/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|