Device Classification Name |
forceps
|
510(k) Number |
K974593 |
Device Name |
SEMKIN INSULATED BIPOLAR FORCEP |
Applicant |
TITAN MFG., INC. |
6 JAMIE LN. |
PHOENIXVILLE,
PA
19460
|
|
Applicant Contact |
DONALD SEAVEY |
Correspondent |
TITAN MFG., INC. |
6 JAMIE LN. |
PHOENIXVILLE,
PA
19460
|
|
Correspondent Contact |
DONALD SEAVEY |
Regulation Number | 878.4800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/09/1997 |
Decision Date | 06/24/1998 |
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
|