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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 K933626
Device Name CAPNO-FLO
Applicant
Kirk Specialty Systems
2735 E. Belt Line Rd.,
Suite 300
Carrollton,  TX  75006
Applicant Contact DALE BICKLEY
Correspondent
Kirk Specialty Systems
2735 E. Belt Line Rd.,
Suite 300
Carrollton,  TX  75006
Correspondent Contact DALE BICKLEY
Regulation Number868.5915
Classification Product Code
BTM  
Date Received07/16/1993
Decision Date 10/06/1993
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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