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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 K970419
Device Name DAXOR MAX100 SYRINGE (MAX100)
Applicant
Daxor Corporation
312 Trossachs Ln.
Knoxville,  TN  37922 -3421
Applicant Contact RONALD H BALDRY
Correspondent
Daxor Corporation
312 Trossachs Ln.
Knoxville,  TN  37922 -3421
Correspondent Contact RONALD H BALDRY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/04/1997
Decision Date 12/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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