Device Classification Name |
insufflator, hysteroscopic
|
510(k) Number |
K971492 |
Device Name |
AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR |
Applicant |
BEI MEDICAL SYSTEMS CO., INC. |
83 HOBART ST. |
HACKENSACK,
NJ
07601
|
|
Applicant Contact |
LORRAINE T MONTEMURRO |
Correspondent |
BEI MEDICAL SYSTEMS CO., INC. |
83 HOBART ST. |
HACKENSACK,
NJ
07601
|
|
Correspondent Contact |
LORRAINE T MONTEMURRO |
Regulation Number | 884.1700
|
Classification Product Code |
|
Date Received | 04/24/1997 |
Decision Date | 09/05/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|