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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port, Protector/Cushion
510(k) Number K062261
Device Name FOAM RING PORT PROTECTOR
Applicant
Inspired Ideas, Incorporated
11460 N.Meridian St.,
Suite 150
Carmel,  IN  46032
Applicant Contact Allison Scott
Correspondent
Inspired Ideas, Incorporated
11460 N.Meridian St.,
Suite 150
Carmel,  IN  46032
Correspondent Contact Allison Scott
Regulation Number880.5965
Classification Product Code
OBK  
Date Received08/04/2006
Decision Date 04/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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