Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K944555 |
Device Name |
ENDOSCOPE |
Applicant |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Applicant Contact |
JONATHAN GILBERT |
Correspondent |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Correspondent Contact |
JONATHAN GILBERT |
Regulation Number | 884.1720
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/16/1994 |
Decision Date | 12/30/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|