Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K910883 |
Device Name |
LAPAROFLATOR ELECTRONIC 3509 |
Applicant |
F.M. WIEST USA, INC. |
P.O. BOX 637 |
ORADEL,
NJ
07649
|
|
Applicant Contact |
GEORGE R BATCHELOR |
Correspondent |
F.M. WIEST USA, INC. |
P.O. BOX 637 |
ORADEL,
NJ
07649
|
|
Correspondent Contact |
GEORGE R BATCHELOR |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 03/01/1991 |
Decision Date | 03/29/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|