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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 K060751
Device Name INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
Applicant
Inovo, Inc.
2975 S. Horseshoe Dr.
Suite 600
Naples,  FL  34104
Applicant Contact MICHAEL T DILDINE
Correspondent
Inovo, Inc.
2975 S. Horseshoe Dr.
Suite 600
Naples,  FL  34104
Correspondent Contact MICHAEL T DILDINE
Regulation Number868.5905
Classification Product Code
NFB  
Date Received03/21/2006
Decision Date 07/18/2006
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
Recalls CDRH Recalls
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