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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 K900637
Device Name BEAR CEM CONTROLLER
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 Number868.5895
Classification Product Code
CBK  
Date Received02/09/1990
Decision Date 08/03/1990
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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