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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 K031983
Device Name INOVO, INC, ECONOMIZER CONSERVING REGULATOR
Applicant
INOVO, INC.
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
INOVO, INC.
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number868.5905
Classification Product Code
NFB  
Date Received06/26/2003
Decision Date 09/15/2003
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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