Device Classification Name |
accessory, assisted reproduction
|
510(k) Number |
K011327 |
Device Name |
DB1 EMBRYO FREEZE |
Applicant |
ZANDER MEDICAL SUPPLIES, INC. |
755 8TH CT., SUITE #4 |
P.O.650790 |
VERO BEACH,
FL
32962
|
|
Applicant Contact |
FRED ZANDER |
Correspondent |
ZANDER MEDICAL SUPPLIES, INC. |
755 8TH CT., SUITE #4 |
P.O.650790 |
VERO BEACH,
FL
32962
|
|
Correspondent Contact |
FRED ZANDER |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 05/01/2001 |
Decision Date | 08/15/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|