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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 K992969
FOIA Releasable 510(k) K992969
Device Name RESPIRONICS TOTAL FACE MASK
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 Number868.5905
Classification Product Code
BZD  
Date Received09/03/1999
Decision Date 11/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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