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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.
299 Ballardvale St., Suite I,
Wilmington,  MA  01887
Correspondent Contact Kathy Dassler
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
Predetermined Change
Control Plan Authorized		 No
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