510(k) K120306

RAPICIDE OPA-28 by Minntech Corp. — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2012
Date Received
February 1, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilant, Medical Devices
Device Class
Class II
Regulation Number
880.6885
Review Panel
HO
Submission Type