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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K061663
Device Name ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES
Applicant
Rtc Inc.-Memcath Technologies, LLC
1777 Oakdale Ave.,
West St. Paul,  MN  55118
Applicant Contact MARC JAKER
Correspondent
Rtc Inc.-Memcath Technologies, LLC
1777 Oakdale Ave.,
West St. Paul,  MN  55118
Correspondent Contact MARC JAKER
Regulation Number874.4760
Classification Product Code
EOB  
Date Received06/05/2006
Decision Date 09/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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