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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 K871101
Device Name 0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.
Applicant
MATHESON GAS PRODUCTS, INC.
932 PATERSON PLANK RD.
EAST RUTHEFORD,  NJ  07073
Applicant Contact DENNIS R DEPOL
Correspondent
MATHESON GAS PRODUCTS, INC.
932 PATERSON PLANK RD.
EAST RUTHEFORD,  NJ  07073
Correspondent Contact DENNIS R DEPOL
Regulation Number868.6400
Classification Product Code
BXK  
Date Received03/19/1987
Decision Date 04/20/1987
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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