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510(k) K894045

MODIFIED POLYCHROME IV STAIN by Devetec, Inc. — Product Code KFD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 25, 1989
Date Received: June 7, 1989
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Aniline Blue
Device Class: Class I
Regulation Number: 864.1850
Review Panel: PA
Submission Type