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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ventricular
510(k) Number K013005
Device Name ACT 11 MP VENTRICULAR CATHETER
Applicant
Innerspace, Inc.
2933 S. Pullman St.,
Suite A
Santa Ana,  CA  92705
Applicant Contact DONALD E BOBO
Correspondent
Innerspace, Inc.
2933 S. Pullman St.,
Suite A
Santa Ana,  CA  92705
Correspondent Contact DONALD E BOBO
Regulation Number882.4100
Classification Product Code
HCA  
Date Received09/06/2001
Decision Date 03/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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