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510(k) K760927

STOMA SHIELD ADAPTER by Rudolfo T. Sanchez — Product Code EXE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 26, 1977
Date Received: October 28, 1976
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Protector, Ostomy
Device Class: Class I
Regulation Number: 876.5900
Review Panel: GU
Submission Type