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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Regulator, Pressure, Gas Cylinder
510(k) Number K865077
Device Name ACCU-FLO REGULATOR
Applicant
ALUM-OX, INC.
215 MASARIK AVE.
STRATFORD,  CT  06497
Applicant Contact DENNIS A MOORE
Correspondent
ALUM-OX, INC.
215 MASARIK AVE.
STRATFORD,  CT  06497
Correspondent Contact DENNIS A MOORE
Regulation Number868.2700
Classification Product Code
CAN  
Date Received12/29/1986
Decision Date 02/10/1987
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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