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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
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