Device Classification Name |
accessory, assisted reproduction
|
510(k) Number |
K023465 |
Device Name |
KENDRO HERACELL 240 INCUBATOR |
Applicant |
KENDRO LABORATORY PRODUCTS, L.P. |
P.O. BOX 2156 |
HUNTINGTON,
CT
06484
|
|
Applicant Contact |
JOSEPH M AZARY |
Correspondent |
KENDRO LABORATORY PRODUCTS, L.P. |
P.O. BOX 2156 |
HUNTINGTON,
CT
06484
|
|
Correspondent Contact |
JOSEPH M AZARY |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 10/15/2002 |
Decision Date | 03/10/2003 |
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
|
|
|