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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 K071461
Device Name MODEL 300D HOME OXYGEN LIQUEFIER
Applicant
COPD PARTNERS, INC.
3460 POINTE CREEK CT.
SUITE 102
BONITA SPRINGS,  FL  34134 -2015
Applicant Contact PAUL DRYDEN
Correspondent
COPD PARTNERS, INC.
3460 POINTE CREEK CT.
SUITE 102
BONITA SPRINGS,  FL  34134 -2015
Correspondent Contact PAUL DRYDEN
Regulation Number868.5440
Classification Product Code
CAW  
Subsequent Product Code
BYJ  
Date Received05/25/2007
Decision Date 08/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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