Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K900988 |
Device Name |
AMCATH SUCTION-IRRIGATION TUBE |
Applicant |
INTL. MEDICAL, INC. |
175 CONNECTICUT MILLS AVE. |
DANIELSON,
CT
06239
|
|
Applicant Contact |
H WETTERMANN |
Correspondent |
INTL. MEDICAL, INC. |
175 CONNECTICUT MILLS AVE. |
DANIELSON,
CT
06239
|
|
Correspondent Contact |
H WETTERMANN |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 03/02/1990 |
Decision Date | 05/07/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|