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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K070884
Device Name POD B-SCAN
Applicant
Starfish Product Engineering, Inc.
#5-555 Ardersier Rd.
Victoria, B.C.,,  CA V8Z 1C8
Applicant Contact DAYRL WISDAHL
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact NEIL E DEVINE, JR.
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received03/30/2007
Decision Date 04/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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