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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filter, bacterial, breathing-circuit
510(k) Number K063526
Device Name A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
Applicant
A-M SYSTEMS, INC.
845 ARONSON LAKE COURT
ROSWELL,  GA  30075
Applicant Contact JAY MANSOUR
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.5260
Classification Product Code
CAH  
Date Received11/22/2006
Decision Date 06/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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