Device Classification Name |
Insufflator, Hysteroscopic
|
510(k) Number |
K872860 |
Device Name |
INSUFFLATOR TUBING |
Applicant |
MEDLINE INDUSTRIES, INC. |
99 INVERNESS DRIVE EAST |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
JO BREHM |
Correspondent |
MEDLINE INDUSTRIES, INC. |
99 INVERNESS DRIVE EAST |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
JO BREHM |
Regulation Number | 884.1700
|
Classification Product Code |
|
Date Received | 07/21/1987 |
Decision Date | 11/16/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|