Device Classification Name |
Dura Substitute
|
510(k) Number |
K982101 |
Device Name |
SHELHIGH NO-REACT DURA SHIELD |
Applicant |
SHELHIGH, INC. |
P.O. BOX 884 |
MILLBURN,
NJ
07041
|
|
Applicant Contact |
SHLOMO GABBAY |
Correspondent |
SHELHIGH, INC. |
P.O. BOX 884 |
MILLBURN,
NJ
07041
|
|
Correspondent Contact |
SHLOMO GABBAY |
Regulation Number | 882.5910
|
Classification Product Code |
|
Date Received | 06/15/1998 |
Decision Date | 05/02/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|