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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 K132124
Device Name KLARITY VACUUM BAG, KLARITY MOLD CUSHION
Applicant
KLARITY MEDICAL PRODUCTS, LLC
80 WESTGATE DRIVE
NEWARK,  OH  43055
Applicant Contact PETER LARSON
Correspondent
KLARITY MEDICAL PRODUCTS, LLC
80 WESTGATE DRIVE
NEWARK,  OH  43055
Correspondent Contact PETER LARSON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/10/2013
Decision Date 11/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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