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510(k) K904389

SI-PRO by David F. Trungale — Product Code EYF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 17, 1990
Date Received: September 26, 1990
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Protector, Wound, Plastic
Device Class: Class I
Regulation Number: 878.4014
Review Panel: SU
Submission Type