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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K852108
Device Name NEWPORT VENTILATOR MODEL E-100
Applicant
Newport Medical Instruments, Inc.
P.O. Box 2600
Newport Beach,  CA  92658
Applicant Contact DOUG DOMURAT
Correspondent
Newport Medical Instruments, Inc.
P.O. Box 2600
Newport Beach,  CA  92658
Correspondent Contact DOUG DOMURAT
Date Received05/15/1985
Decision Date 09/18/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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