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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K930957
Device Name ZEFON GAS SAMPLING LINES
Applicant
Zefon Medical Products
5350 Southwest First Ln.
Ocala,  FL  34474
Applicant Contact ROBERT STONE
Correspondent
Zefon Medical Products
5350 Southwest First Ln.
Ocala,  FL  34474
Correspondent Contact ROBERT STONE
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/23/1993
Decision Date 07/02/1993
Decision Substantially Equivalent - Kit (SESK)
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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