Device Classification Name |
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
|
510(k) Number |
K003405 |
Device Name |
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO |
Applicant |
HIGHLAND / MARIETTA, INC. |
6155 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Applicant Contact |
JOHN NIKSA |
Correspondent |
HIGHLAND / MARIETTA, INC. |
6155 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
JOHN NIKSA |
Regulation Number | 884.4160
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/01/2000 |
Decision Date | 05/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|