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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 K944998
Device Name CALIBRATION GAS
Applicant
SUNOX, INC.
4236 STATESVILLE RD.
CHARLOTTE,  NC  28269
Applicant Contact MARK DAIDONE
Correspondent
SUNOX, INC.
4236 STATESVILLE RD.
CHARLOTTE,  NC  28269
Correspondent Contact MARK DAIDONE
Regulation Number868.6400
Classification Product Code
BXK  
Date Received10/13/1994
Decision Date 02/03/1995
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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