FDA 510(k) Applications Submitted by BETSY CORTELLONI
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K990199 |
01/21/1999 |
SMARTRECORDER, MODEL 2500 |
RESPIRONICS, INC. |
| K060987 |
04/10/2006 |
OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 |
CP MEDICAL |
| K991627 |
05/11/1999 |
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 |
RESPIRONICS, INC. |
| K011597 |
05/24/2001 |
SMARTMONITOR 2, MODEL 4000 |
RESPIRONICS GEORGIA, INC. |
| K071550 |
06/06/2007 |
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS |
CP MEDICAL |
| K972614 |
07/14/1997 |
TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605 |
HEALTHDYNE TECHNOLOGIES, INC. |
| K982550 |
07/22/1998 |
BROWSER (EVENT SOFTWARE) MODEL # 4500E |
RESPIRONICS, INC. |
| K072229 |
08/10/2007 |
MONOSWIFT |
CP MEDICAL |
| K072296 |
08/17/2007 |
POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 |
THERAGENICS CORP. |
| K112398 |
08/19/2011 |
TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT |
GALT MEDICAL |
| K983572 |
10/13/1998 |
SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 |
HEALTHDYNE TECHNOLOGIES, INC. |
| K043596 |
12/29/2004 |
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 |
THERAGENICS CORP. |
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