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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K924152
Device Name KEYSTONE CONCENTRATOR, MODEL PV5L
Applicant
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Applicant Contact ROBERT A COBLENTZ
Correspondent
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Correspondent Contact ROBERT A COBLENTZ
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/18/1992
Decision Date 06/07/1993
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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