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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
Predetermined Change
Control Plan Authorized		 No
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