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510(k) K922110

GO-CLEAN by Viva-Tek Assoc., Inc. — Product Code FRR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 9, 1994
Date Received: May 5, 1992
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Chamber, Reverse Isolation, Patient Care
Device Class: Class II
Regulation Number: 880.5450
Review Panel: HO
Submission Type