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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K162500
Device Name Ostial Sprit Cannulae
Applicant
Spyder Medical
22521 Avenida Empresa, Suite 111
Rancho Santa Margarita,  CA  92688
Applicant Contact MICHAEL WEBB
Correspondent
Spyder Medical
22521 Avenida Empresa, Suite 111
Rancho Santa Margarita,  CA  92688
Correspondent Contact MICHAEL WEBB
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/07/2016
Decision Date 01/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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