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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Illuminator, Fiberoptic, Surgical Field
510(k) Number K921866
Device Name LUMINOUS 250 FIBEROPTIC ILLUMINATOR
Applicant
Progressive Dynamics, Inc.
507 Industrial Rd.
Marshall,  MI  49068
Applicant Contact WILLIAM F LOHNESS
Correspondent
Progressive Dynamics, Inc.
507 Industrial Rd.
Marshall,  MI  49068
Correspondent Contact WILLIAM F LOHNESS
Regulation Number878.4580
Classification Product Code
HBI  
Date Received04/20/1992
Decision Date 07/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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