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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K042232
Device Name NP-2600 SERIES HARDCOPY PRINTERS
Applicant
Codonics, Inc.
17991 Englewood Dr.
Middleburg Heights,  OH  44130
Applicant Contact ALAN DESANTIS
Correspondent
Codonics, Inc.
17991 Englewood Dr.
Middleburg Heights,  OH  44130
Correspondent Contact ALAN DESANTIS
Regulation Number892.2040
Classification Product Code
LMC  
Date Received08/17/2004
Decision Date 10/05/2004
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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