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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K081524
Device Name SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L
Applicant
Spectra Medical Devices, Inc.
4501 Greendale Dr.
Williamsburg,  VA  23188
Applicant Contact SCOTT HENDERSON
Correspondent
Spectra Medical Devices, Inc.
4501 Greendale Dr.
Williamsburg,  VA  23188
Correspondent Contact SCOTT HENDERSON
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/02/2008
Decision Date 07/29/2008
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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