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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas, Calibration (Specified Concentration)
510(k) Number K944812
Device Name CLINICAL BLOOD GAS MIXTURE
Applicant
Laboratory & Specialty Gases, Inc.
1180 N. Marshall Ave.
El Lajon,  CA  92020
Applicant Contact FRANK J DILATURO
Correspondent
Laboratory & Specialty Gases, Inc.
1180 N. Marshall Ave.
El Lajon,  CA  92020
Correspondent Contact FRANK J DILATURO
Regulation Number868.6400
Classification Product Code
BXK  
Date Received09/29/1994
Decision Date 02/01/1995
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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