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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Beam Limiting, X-Ray, Diagnostic
510(k) Number K062788
Device Name COLLIMATOR, MODEL M-38
Applicant
Umi International
129 Kensington Ave.
Norwood,  NJ  07648
Applicant Contact KWANG C JUNG
Correspondent
Umi International
129 Kensington Ave.
Norwood,  NJ  07648
Correspondent Contact KWANG C JUNG
Regulation Number892.1610
Classification Product Code
KPW  
Date Received09/18/2006
Decision Date 12/28/2006
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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