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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K952512
Device Name CAPNO-FLO REGULATOR, CAPNO-FLO
Applicant
Kirk Specialty Systems
1625 Crescent Cir., Suite 225
Carrollton,  TX  75006
Applicant Contact DALE BICKLEY
Correspondent
Kirk Specialty Systems
1625 Crescent Cir., Suite 225
Carrollton,  TX  75006
Correspondent Contact DALE BICKLEY
Regulation Number868.5915
Classification Product Code
BTM  
Date Received05/30/1995
Decision Date 08/28/1995
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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