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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K921215
Device Name LASERSTAR IMAGER
Applicant
Frantz Imaging, Inc.
17744 Skypark Blvd.
Suite 165
Irvine,  CA  92714
Applicant Contact DALE E MCDANIEL
Correspondent
Frantz Imaging, Inc.
17744 Skypark Blvd.
Suite 165
Irvine,  CA  92714
Correspondent Contact DALE E MCDANIEL
Regulation Number892.2040
Classification Product Code
LMC  
Date Received03/13/1992
Decision Date 02/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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