Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K945741 |
Device Name |
TROCAR AND CANNULA ACCESSORY |
Applicant |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE |
BUILDING 104 |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
MARY JO STEGWELL |
Correspondent |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE |
BUILDING 104 |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
MARY JO STEGWELL |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 11/23/1994 |
Decision Date | 02/28/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|