Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K923528 |
Device Name |
INLET IRRIGATION/ASPIRATION VALVE AND PROBES |
Applicant |
INLET MEDICAL, INC. |
6470 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
CONSTANCE G BUNDY |
Correspondent |
INLET MEDICAL, INC. |
6470 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
CONSTANCE G BUNDY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/16/1992 |
Decision Date | 01/12/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|