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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K980551
Device Name SILENZIO DELTA 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 Number868.5905
Classification Product Code
BZD  
Date Received02/12/1998
Decision Date 11/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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