Device Classification Name |
needle, assisted reproduction
|
510(k) Number |
K991262 |
Device Name |
SINGLE LUMEN NEEDLE |
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 | 884.6100
|
Classification Product Code |
|
Date Received | 04/13/1999 |
Decision Date | 09/09/1999 |
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
|
|
|