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510(k) K813190

SOFT PLATE CUSHION by Leonard Russo Co. — Product Code EHS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 5, 1982
Date Received: November 16, 1981
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Cushion, Denture, Over The Counter
Device Class: Class II
Regulation Number: 872.3540
Review Panel: DE
Submission Type