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510(k) K823127

ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL by Syva Co. — Product Code LAZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1982
Date Received
October 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
N-Acetylprocainamide Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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