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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 K103740
Device Name SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
Applicant
SPECTRA MEDICAL DEVICES, INC.
3000 K ST., NW
WASHINGTON,  DC  20007
Applicant Contact DAVID L ROSEN, B.S. PHARM., J.D.
Correspondent
SPECTRA MEDICAL DEVICES, INC.
3000 K ST., NW
WASHINGTON,  DC  20007
Correspondent Contact DAVID L ROSEN, B.S. PHARM., J.D.
Regulation Number880.5200
Classification Product Code
NGT  
Date Received12/22/2010
Decision Date 07/29/2011
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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