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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name saline, vascular access flush
510(k) Number K082689
Device Name STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
Applicant
SPECTRA MEDICAL DEVICES, INC.
3000 K ST., NW
WASHINGTON,  DC  20007
Applicant Contact DAVID L ROSEN
Correspondent
SPECTRA MEDICAL DEVICES, INC.
3000 K ST., NW
WASHINGTON,  DC  20007
Correspondent Contact DAVID L ROSEN
Regulation Number880.5200
Classification Product Code
NGT  
Date Received09/15/2008
Decision Date 03/20/2009
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 No
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