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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K133204
Device Name AIRVIEW MINI OWIE DICK TEST PACK
Applicant
Crosstex International
6789 W. Henrietta Rd.
Rush,  NY  14543
Applicant Contact MICHAEL G NOLAN
Correspondent
Crosstex International
6789 W. Henrietta Rd.
Rush,  NY  14543
Correspondent Contact MICHAEL G NOLAN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received10/17/2013
Decision Date 05/05/2014
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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