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510(k) K970510

INNOFLOUR TOPIRAMATE REAGENT SET by Oxis Intl., Inc. — Product Code MSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1997
Date Received
February 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Topiramatee
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

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