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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, monitoring, intracranial pressure
510(k) Number K083378
Device Name SYNERGY
Applicant
INNERSPACE, INC.
1622 EDINGER AVENUE, SUITE C
TUSTIN,  CA  92780
Applicant Contact DON BOBO
Correspondent
INNERSPACE, INC.
1622 EDINGER AVENUE, SUITE C
TUSTIN,  CA  92780
Correspondent Contact DON BOBO
Regulation Number882.1620
Classification Product Code
GWM  
Date Received11/14/2008
Decision Date 09/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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