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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 K020730
Device Name ORION NASAL CPAP SYSTEM
Applicant
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Applicant Contact TOM GUITERREZ
Correspondent
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Correspondent Contact TOM GUITERREZ
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/06/2002
Decision Date 05/22/2002
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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