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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Ventricular
510(k) Number K150660
Device Name Alcyone MEMS Cannula (AMC) System
Applicant
Alcyone Lifesciences, Inc.
130 John St., Boot Canal Mill Bldg., C-2
Lowell,  MA  01852
Applicant Contact ELSA CHI ABRUZZO
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number882.4060
Classification Product Code
HCD  
Date Received03/13/2015
Decision Date 04/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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