Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K981389 |
Device Name |
DISPOSABLE RE-NEW FORCEPS |
Applicant |
MICROLINE PENTAX, INC. |
70 WALNUT ST. |
WELLESLEY,
MA
02481 -2102
|
|
Applicant Contact |
JACQUELINE E MASSE |
Correspondent |
MICROLINE PENTAX, INC. |
70 WALNUT ST. |
WELLESLEY,
MA
02481 -2102
|
|
Correspondent Contact |
JACQUELINE E MASSE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/16/1998 |
Decision Date | 05/29/1998 |
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
|
Recalls |
CDRH Recalls
|