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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Nitric Oxide Delivery
510(k) Number K120216
FOIA Releasable 510(k) K120216
Device Name GENOSYL MV-1000
Applicant
GENO LLC
2941 OXBOW CIRCLE
COCOA,  FL  32926
Applicant Contact PAUL DRYDEN
Correspondent
GENO LLC
2941 OXBOW CIRCLE
COCOA,  FL  32926
Correspondent Contact PAUL DRYDEN
Regulation Number868.5165
Classification Product Code
MRN  
Date Received01/24/2012
Decision Date 05/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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