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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K120306
FOIA Releasable 510(k) K120306
Device Name RAPICIDE OPA-28
Applicant
Minntech Corp.
14605 28th Ave. N.
Minneapolis,  MN  55447
Applicant Contact BRENT GREIGER, MS, RAC
Correspondent
Minntech Corp.
14605 28th Ave. N.
Minneapolis,  MN  55447
Correspondent Contact BRENT GREIGER, MS, RAC
Regulation Number880.6885
Classification Product Code
MED  
Date Received02/01/2012
Decision Date 09/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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