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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Liquid-Oxygen, Portable
510(k) Number K853775
Device Name PENOX HIGH FLOW MANIFOLD
Applicant
PENOX TECHNOLOGIES, INC.
ONE PENOX PLAZA, COMMERCE RD.
P.O. BOX 785
PITTSTON,  PA  18640
Applicant Contact THANA A FRANCE
Correspondent
PENOX TECHNOLOGIES, INC.
ONE PENOX PLAZA, COMMERCE RD.
P.O. BOX 785
PITTSTON,  PA  18640
Correspondent Contact THANA A FRANCE
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received09/10/1985
Decision Date 11/29/1985
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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