Device Classification Name |
accessory, assisted reproduction
|
510(k) Number |
K001524 |
Device Name |
FORMA SCIENTIFIC DIRECT HEAT INCUBATORS |
Applicant |
THERMOQUEST CORP. |
MILL CREEK RD. |
MARIETTA,
OH
45750
|
|
Applicant Contact |
RICHARD L MILLER |
Correspondent |
THERMOQUEST CORP. |
MILL CREEK RD. |
MARIETTA,
OH
45750
|
|
Correspondent Contact |
RICHARD L MILLER |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 05/16/2000 |
Decision Date | 07/12/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|