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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 K024023
Device Name ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
Applicant
Essex Medical Systems Plus
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Essex Medical Systems Plus
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number868.5905
Classification Product Code
NFB  
Date Received12/05/2002
Decision Date 10/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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