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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, Lead (Dedicated Instruments)
510(k) Number K944226
Device Name MSI PROCEDURE KIT
Applicant
Msi, Inc.
615 Jasmine Ave. N.
Tarpon Springs,  FL  34689
Applicant Contact LARRY G JUNKER
Correspondent
Msi, Inc.
615 Jasmine Ave. N.
Tarpon Springs,  FL  34689
Correspondent Contact LARRY G JUNKER
Regulation Number862.3550
Classification Product Code
DOX  
Date Received08/30/1994
Decision Date 06/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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