Device Classification Name |
mesh, surgical
|
510(k) Number |
K991567 |
Device Name |
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. |
Applicant |
SHELHIGH, INC. |
67 E. WILLOW ST. |
MILLBURN,
NJ
07041
|
|
Applicant Contact |
SHLOMO GABBAY |
Correspondent |
SHELHIGH, INC. |
67 E. WILLOW ST. |
MILLBURN,
NJ
07041
|
|
Correspondent Contact |
SHLOMO GABBAY |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 05/05/1999 |
Decision Date | 07/14/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|