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510(k) K953761

AXSYM TRICYCLIC ANTIDEPRESSANTS by Abbott Laboratories — Product Code LFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1995
Date Received
August 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
U.V. Spectrometry, Tricyclic Antidepressant Drugs
Device Class
Class II
Regulation Number
862.3910
Review Panel
TX
Submission Type

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