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FDA 510(k) Application Details - K062260
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K062260
Device Name
Syringe, Piston
Applicant
ORTHOS LIMITED
3 THE STABLES LEIGH CT PILL RD
ABBOTS LEIGH
BRISTOL, NORTH SOMERSET BS8 3RA GB
Other 510(k) Applications for this Company
Contact
ALAN RORKE
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Regulation Number
880.5860
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Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
08/04/2006
Decision Date
10/26/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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