|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
QUICKAIR CHOKE RELIEVER, MODEL 59-001A
|
MAET INDUSTRIES, INC. |
DEN000004 |
K993284 |
02/29/2000 |
WALLAC NEONATAL BIOTINIDASE TEST KIT, MO
|
WALLAC, INC. |
DEN990008 |
K992284 |
02/15/2000 |
UROSURGE PERCUTANEOUS SANS (STOLLER AFFE
|
UROSURGE, INC. |
DEN000002 |
K992069 |
02/09/2000 |
THE 3PM EGG MACHINE
|
3PM CO., INC. |
DEN990005 |
K984637 |
08/20/1999 |
KAVO DIAGNODENT
|
KAVO AMERICA |
DEN990002 |
K983658 |
02/22/2000 |
DIAMOND PROBE/PERIO 2000 SYSTEM
|
DIAMOND GENERAL DEVELOPMENT CORP. |
DEN980003 |
K980749 |
07/17/1998 |
OHMEDA INOVENT DELIVERY SYSTEM
|
OHMEDA MEDICAL |
DEN000001 |
K974562 |
01/11/2000 |
DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC
|
CRANIAL TECHNOLOGIES, INC. |
DEN980001 |
K964992 |
05/29/1998 |
LYRA DIRECT STREP ASSAY
|
QUIDEL CORPORATION |
DEN140005 |
K133883 |
04/16/2014 |
SIMPLEXA HSV 1&2 DIRECT
|
FOCUS DIAGNOSTICS |
DEN130049 |
K133621 |
03/21/2014 |