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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 K053240
Device Name DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES
Applicant
SUNRISE MEDICAL
100 DEVILBISS DRIVE
SOMERSET,  PA  15501
Applicant Contact JOSEPH E OLSAVSKY
Correspondent
SUNRISE MEDICAL
100 DEVILBISS DRIVE
SOMERSET,  PA  15501
Correspondent Contact JOSEPH E OLSAVSKY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/18/2005
Decision Date 02/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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