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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, Facility Use
510(k) Number K992788
Device Name BEAR CUB 750 PSV
Applicant
BEAR MEDICAL SYSTEMS, INC.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Applicant Contact DARRYL SHELBY
Correspondent
BEAR MEDICAL SYSTEMS, INC.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Correspondent Contact DARRYL SHELBY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/19/1999
Decision Date 09/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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