Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K973379 |
Device Name |
STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS |
Applicant |
S. JACKSON, INC. |
15 ROTH ST. |
P.O. BOX 4487 |
ALEXANDRIA,
VA
22303
|
|
Applicant Contact |
J. JACKSON |
Correspondent |
S. JACKSON, INC. |
15 ROTH ST. |
P.O. BOX 4487 |
ALEXANDRIA,
VA
22303
|
|
Correspondent Contact |
J. JACKSON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 09/08/1997 |
Decision Date | 09/25/1997 |
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
|
|
|