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510(k) K970419

DAXOR MAX100 SYRINGE (MAX100) by Daxor Corporation — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1997
Date Received
February 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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