Device Classification Name |
Accessory, Assisted Reproduction
|
510(k) Number |
K001486 |
Device Name |
GENX CODA AIR PURIFICATION SYSTEM |
Applicant |
<GENX> INTL., INC. |
170 FORT PATH RD. |
UNIT 14 |
MADISON,
CT
06443
|
|
Applicant Contact |
MICHAEL D CECCHI |
Correspondent |
INTL., INC. |
170 FORT PATH RD. |
UNIT 14 |
MADISON,
CT
06443
|
|
Correspondent Contact |
MICHAEL D CECCHI |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 05/12/2000 |
Decision Date | 09/15/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|