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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 K021084
Device Name LIGHT SABER SPINAL NEEDLE
Applicant
Minrad, Inc.
847 Main St.
Buffalo,  NY  14203
Applicant Contact KIM S DEVITO
Correspondent
Minrad, Inc.
847 Main St.
Buffalo,  NY  14203
Correspondent Contact KIM S DEVITO
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
IWE  
Date Received04/04/2002
Decision Date 07/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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