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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K896315
Device Name BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
Applicant
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Applicant Contact STANLEY E FRY
Correspondent
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Correspondent Contact STANLEY E FRY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received11/01/1989
Decision Date 01/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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