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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K093489
FOIA Releasable 510(k) K093489
Device Name IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY
Applicant
RYMED TECHNOLOGIES, INC.
80 SHELTON TECHNOLOGY CENTER
SHELTON,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
RYMED TECHNOLOGIES, INC.
80 SHELTON TECHNOLOGY CENTER
SHELTON,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/10/2009
Decision Date 07/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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