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510(k) K954401

GASTROTEC by Patrick C. Jacobssen — Product Code ESI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 25, 1996
Date Received: September 20, 1995
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Polymer, Natural-Absorbable Gelatin Material
Device Class: Class III
Regulation Number
Review Panel: EN
Submission Type