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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 K860848
Device Name VITAL FLOW NASAL CPAP SYSTEM
Applicant
Systems 2000, Inc.
Attorney At Law
2085 Rustin Ave.
Riverside,  CA  92507
Applicant Contact STANLEY E FRY
Correspondent
Systems 2000, Inc.
Attorney At Law
2085 Rustin Ave.
Riverside,  CA  92507
Correspondent Contact STANLEY E FRY
Regulation Number868.5965
Classification Product Code
BYE  
Date Received03/06/1986
Decision Date 06/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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