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510(k) K896364

DECIDENT by Nevin Laboratories, Inc. — Product Code EKY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 19, 1990
Date Received: November 6, 1989
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Handpiece, Water-Powered
Device Class: Class I
Regulation Number: 872.4200
Review Panel: DE
Submission Type