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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K022708
Device Name KLARITY
Applicant
Larson Products, Inc.
2844 Banwick Rd.
Columbus,  OH  43232 -2115
Applicant Contact PETER M LARSON
Correspondent
Larson Products, Inc.
2844 Banwick Rd.
Columbus,  OH  43232 -2115
Correspondent Contact PETER M LARSON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/14/2002
Decision Date 11/12/2002
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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