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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 K140703
Device Name OPA 30 SOLUTION
Applicant
Ciden Technologies, LLC
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact COURTNEY CLARK
Correspondent
Ciden Technologies, LLC
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact COURTNEY CLARK
Regulation Number880.6885
Classification Product Code
MED  
Date Received03/20/2014
Decision Date 08/19/2014
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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