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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K080516
Device Name LAMIN AIR
Applicant
REMGENIC LLC
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
REMGENIC LLC
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/25/2008
Decision Date 06/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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