Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K915694 |
Device Name |
MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR |
Applicant |
MEDICAL DEVICES, INC. |
83 HOBART ST. |
HACKENSACK,
NJ
07601
|
|
Applicant Contact |
SAMUEL DICKSTEIN |
Correspondent |
MEDICAL DEVICES, INC. |
83 HOBART ST. |
HACKENSACK,
NJ
07601
|
|
Correspondent Contact |
SAMUEL DICKSTEIN |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 12/23/1991 |
Decision Date | 06/18/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|