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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name attachment, breathing, positive end expiratory pressure
510(k) Number K962492
Device Name SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
Applicant
NIDEK MEDICAL PRODUCTS, INC.
3949 VALLEY EAST INDUSTRIAL DR
BIRMINGHAM,  AL  35217
Applicant Contact GREGG GASKINS
Correspondent
NIDEK MEDICAL PRODUCTS, INC.
3949 VALLEY EAST INDUSTRIAL DR
BIRMINGHAM,  AL  35217
Correspondent Contact GREGG GASKINS
Regulation Number868.5965
Classification Product Code
BYE  
Date Received06/26/1996
Decision Date 01/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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