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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image, Illumination, Fiberoptic, For Endoscope
510(k) Number K944688
Device Name LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR
Applicant
Progressive Dynamics, Inc.
507 Industrial Rd.
Marshall,  MI  49068
Applicant Contact TOM PHILIPOT
Correspondent
Progressive Dynamics, Inc.
507 Industrial Rd.
Marshall,  MI  49068
Correspondent Contact TOM PHILIPOT
Regulation Number876.1500
Classification Product Code
FFS  
Date Received09/22/1994
Decision Date 11/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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