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FDA 510(k) Application Details - K081524
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K081524
Device Name
Syringe, Piston
Applicant
SPECTRA MEDICAL DEVICES, INC.
4501 GREENDALE DRIVE
WILLIAMSBURG, VA 23188 US
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Contact
SCOTT HENDERSON
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/2008
Decision Date
07/29/2008
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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