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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Film Marking, Radiographic
510(k) Number K852160
Device Name RADIOLOGICAL MARKING PEN
Applicant
Truett Laboratories, Inc.
798 N. Coney Ave.
Azusa,  CA  91702
Applicant Contact NEAL GOODWIN
Correspondent
Truett Laboratories, Inc.
798 N. Coney Ave.
Azusa,  CA  91702
Correspondent Contact NEAL GOODWIN
Regulation Number892.1640
Classification Product Code
JAC  
Date Received02/28/1985
Decision Date 07/18/1985
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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