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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 K954804
Device Name LUNG DIFFUSION MIXTURES
Applicant
Mittler Supply, Inc.
3607 S. Main St.
South Bend,  IN  46614
Applicant Contact DAVID FINNEY
Correspondent
Mittler Supply, Inc.
3607 S. Main St.
South Bend,  IN  46614
Correspondent Contact DAVID FINNEY
Regulation Number868.6400
Classification Product Code
BXK  
Date Received10/19/1995
Decision Date 01/25/1996
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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