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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 K953934
Device Name MED-TECH LUNG DIFFUSION MIXTURE
Applicant
MEDICAL TECHNICAL GASES INC..
20 HALL ST.
MEDFORD,  MA  02155
Applicant Contact RAMESH V KAPUR
Correspondent
MEDICAL TECHNICAL GASES INC..
20 HALL ST.
MEDFORD,  MA  02155
Correspondent Contact RAMESH V KAPUR
Regulation Number868.6400
Classification Product Code
BXK  
Date Received08/18/1995
Decision Date 09/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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