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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 K060549
Device Name AUTOMOBILE LIGHTER POWER CORD
Applicant
PULMONETIC SYSTEMS, INC.
117400 MEDINA RD.
SUITE 100
MINNEAPOLIS,  MN  55447 -1341
Applicant Contact ROBERT C SAMEC
Correspondent
PULMONETIC SYSTEMS, INC.
117400 MEDINA RD.
SUITE 100
MINNEAPOLIS,  MN  55447 -1341
Correspondent Contact ROBERT C SAMEC
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/02/2006
Decision Date 05/04/2006
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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