Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K971472 |
Device Name |
SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA |
Applicant |
TECHNICAL PRODUCTS, INC. |
2416 PARK CENTRAL BLVD. |
DECATUR,
GA
30035
|
|
Applicant Contact |
NORBERT D THOMPSON |
Correspondent |
TECHNICAL PRODUCTS, INC. |
2416 PARK CENTRAL BLVD. |
DECATUR,
GA
30035
|
|
Correspondent Contact |
NORBERT D THOMPSON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/23/1997 |
Decision Date | 07/01/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|