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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, Nitrogen, Gaseous-Phase
510(k) Number K771516
Device Name CAPILLARY SAMPLE LINE
Applicant
Mcgaw Respiratory Therapy
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Mcgaw Respiratory Therapy
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.1690
Classification Product Code
CCI  
Date Received08/08/1977
Decision Date 08/16/1977
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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