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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K083645
Device Name RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS
Applicant
5 Star Medical, Inc.
11515 Prosperous Dr.
Odessa,  FL  33556
Applicant Contact TERRY L ANCAR
Correspondent
5 Star Medical, Inc.
11515 Prosperous Dr.
Odessa,  FL  33556
Correspondent Contact TERRY L ANCAR
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/09/2008
Decision Date 02/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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