Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K010510 |
Device Name |
BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 |
Applicant |
A & A MEDICAL, INC. |
9370 INDUSTRIAL TRACE |
ALPHARETTA,
GA
30004 -3383
|
|
Applicant Contact |
JIHAD (JAY) MANSOUR |
Correspondent |
A & A MEDICAL, INC. |
9370 INDUSTRIAL TRACE |
ALPHARETTA,
GA
30004 -3383
|
|
Correspondent Contact |
JIHAD (JAY) MANSOUR |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 02/21/2001 |
Decision Date | 05/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|