Device Classification Name |
system, assisted reproduction laser
|
De Novo Number |
DEN040009 |
510(K) Number |
K040045
|
Device Name |
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) |
Requester |
HAMILTON THORNE BIOSCIENCES |
100 cummings center, |
suite 465e |
beverly,
MA
01915
|
|
Contact |
diarmaid douglas-hamilton |
|
Regulation Number | 884.6200
|
Classification Product Code |
|
Date Received | 08/25/2004 |
Decision Date | 11/04/2004 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Obstetrics/Gynecology
|
Review Advisory Committee |
Obstetrics/Gynecology
|
Reclassification Order |
Reclassification Order
|
Type |
Post-NSE
|
|
|