Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K955168 |
Device Name |
SURGICAL CUTTER |
Applicant |
PROMEX, INC. |
1125 BROOKSIDE AVE. |
SUITE G500 |
INDIANAPOLIS,
IN
46202
|
|
Applicant Contact |
JOSEPH L MARK |
Correspondent |
PROMEX, INC. |
1125 BROOKSIDE AVE. |
SUITE G500 |
INDIANAPOLIS,
IN
46202
|
|
Correspondent Contact |
JOSEPH L MARK |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 11/13/1995 |
Decision Date | 01/22/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|