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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 K080391
Device Name DRIVE SOLSTICE OXYGEN CONCENTRATOR
Applicant
Medical Depot
962 Allegro Lane
Apollo Beach,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received02/13/2008
Decision Date 03/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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