Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K941094 |
Device Name |
INSUFFLATION TUBING & FILTER |
Applicant |
H & C CHEMICAL, INC. |
100 NORTH 6TH ST. |
SUITE 960C |
MINNEAPOLIS,
MN
55403
|
|
Applicant Contact |
BRIAN BUTLER |
Correspondent |
H & C CHEMICAL, INC. |
100 NORTH 6TH ST. |
SUITE 960C |
MINNEAPOLIS,
MN
55403
|
|
Correspondent Contact |
BRIAN BUTLER |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 03/08/1994 |
Decision Date | 05/10/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|