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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K020329
Device Name DEVILBISS PD1000
Applicant
SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET,  PA  15501
Applicant Contact BRIAN HERSHEY
Correspondent
SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET,  PA  15501
Correspondent Contact BRIAN HERSHEY
Regulation Number868.5905
Classification Product Code
NFB  
Date Received01/31/2002
Decision Date 06/19/2002
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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