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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, Minimal Ventilatory Support, Facility Use
510(k) Number K990574
Device Name STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
Applicant
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville,  PA  15668
Applicant Contact DAVID J VANELLA
Correspondent
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville,  PA  15668
Correspondent Contact DAVID J VANELLA
Regulation Number868.5895
Classification Product Code
MNT  
Date Received02/23/1999
Decision Date 05/24/1999
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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