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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K000859
Device Name OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
Applicant
Charles A. Smith
811 Starlite Dr.
Louisville,  KY  40207
Applicant Contact CHARLES A SMITH
Correspondent
Charles A. Smith
811 Starlite Dr.
Louisville,  KY  40207
Correspondent Contact CHARLES A SMITH
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received03/17/2000
Decision Date 08/23/2000
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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