Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K921837 |
Device Name |
MEDICAM 900 INSUFFLATOR WITH ACCESSORIES |
Applicant |
KIRSCHNER MEDICAL CORP. |
9690 DEERECO ROADD |
TIMONIUM,
MD
21093
|
|
Applicant Contact |
SAM SON |
Correspondent |
KIRSCHNER MEDICAL CORP. |
9690 DEERECO ROADD |
TIMONIUM,
MD
21093
|
|
Correspondent Contact |
SAM SON |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 04/17/1992 |
Decision Date | 02/05/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|