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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 K032822
Device Name ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
Applicant
Asap Endoscopic Products GmbH
Katharinenstr. 5
Luebeck,  DE 23554
Applicant Contact MARTINA GUENDEROTH
Correspondent
Asap Endoscopic Products GmbH
Katharinenstr. 5
Luebeck,  DE 23554
Correspondent Contact MARTINA GUENDEROTH
Regulation Number874.4760
Classification Product Code
EOB  
Date Received09/10/2003
Decision Date 01/08/2004
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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