|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC
|
CRANIAL TECHNOLOGIES, INC. |
DEN980001 |
K964992 |
05/29/1998 |
DIAMOND PROBE/PERIO 2000 SYSTEM
|
DIAMOND GENERAL DEVELOPMENT CORP. |
DEN980003 |
K980749 |
07/17/1998 |
THE 3PM EGG MACHINE
|
3PM CO., INC. |
DEN990005 |
K984637 |
08/20/1999 |
OHMEDA INOVENT DELIVERY SYSTEM
|
OHMEDA MEDICAL |
DEN000001 |
K974562 |
01/11/2000 |
UROSURGE PERCUTANEOUS SANS (STOLLER AFFE
|
UROSURGE, INC. |
DEN000002 |
K992069 |
02/09/2000 |
WALLAC NEONATAL BIOTINIDASE TEST KIT, MO
|
WALLAC, INC. |
DEN990008 |
K992284 |
02/15/2000 |
KAVO DIAGNODENT
|
KAVO AMERICA |
DEN990002 |
K983658 |
02/22/2000 |
QUICKAIR CHOKE RELIEVER, MODEL 59-001A
|
MAET INDUSTRIES, INC. |
DEN000004 |
K993284 |
02/29/2000 |
EROS-CLITORAL THERAPY DEVICE (CTD)
|
UROMETRICS, INC. |
DEN000006 |
K000280 |
04/28/2000 |
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELI
|
INOVA DIAGNOSTICS, INC. |
DEN000007 |
K000732 |
08/16/2000 |