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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Unit, Liquid-Oxygen, Portable
510(k) Number K072011
Device Name COPD LIQUID OXYGEN PORTABLE, MODEL 300P
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 Number868.5655
Classification Product Code
BYJ  
Date Received07/23/2007
Decision Date 10/18/2007
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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