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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K120753
Device Name CLARISCT
Applicant
Icrco, Inc.
2580 W. 237th St.
Torrance,  CA  90505
Applicant Contact GREG WACHTLER
Correspondent
Icrco, Inc.
2580 W. 237th St.
Torrance,  CA  90505
Correspondent Contact GREG WACHTLER
Regulation Number892.1750
Classification Product Code
OAS  
Date Received03/13/2012
Decision Date 07/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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