FDA 510(k) Application Details - K110792

Device Classification Name Anoscope And Accessories

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510(K) Number K110792
Device Name Anoscope And Accessories
Applicant APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
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Contact FRANS VANDENBROEK
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Regulation Number 876.1500

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Classification Product Code FER
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Date Received 03/21/2011
Decision Date 05/23/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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