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FDA 510(k) Applications Submitted by ANDREW ZELTWANGER
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140186
01/24/2014
THE STORK OTC
RINOVUM WOMEN'S HEALTH, INC
K082558
09/04/2008
COMFORTLITE NASAL MASK
RESPIRONICS, INC.
K082866
09/29/2008
REVOLUTIONFULL FACE MASK
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K091271
04/30/2009
RESPIRONICS PERFORMAX TOTAL FACE MASK
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K031483
05/12/2003
MEDRAD MANUAL SYRINGE LOADER
MEDRAD, INC.
K031808
06/12/2003
MEDRAD SWABBABLE VALVE TRANSFER SET
MEDRAD, INC.
K032771
09/08/2003
MEDRAD CONTINUUM MR INFUSION SYSTEM
MEDRAD, INC.
K082654
09/12/2008
ENTERAL ONLY EXTENSION SET
RESPIRONICS, INC.
K083874
12/29/2008
GALAXY
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
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