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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K082351
Device Name NEPTUNE HYPERBARIC VENTILATOR
Applicant
LEVEL-5, INC.
555 THIRTEENTH ST., NW
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
LEVEL-5, INC.
555 THIRTEENTH ST., NW
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/15/2008
Decision Date 01/02/2009
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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