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510(k) K831502

NEPHROLYTE by Flaitron Laboratories, Inc. — Product Code KFC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 18, 1983
Date Received: May 11, 1983
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Methylene Blue, Tissue Stain
Device Class: Class I
Regulation Number: 864.1850
Review Panel: PA
Submission Type