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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 K933593
Device Name LUMINOUS 150 FIBEROPTIC ILLUMINATOR
Applicant
PROGRESSIVE DYNAMICS, INC.
507 INDUSTRIAL RD.
MARSHALL,  MI  49068 -1796
Applicant Contact TOM PHLIPOT
Correspondent
PROGRESSIVE DYNAMICS, INC.
507 INDUSTRIAL RD.
MARSHALL,  MI  49068 -1796
Correspondent Contact TOM PHLIPOT
Regulation Number878.4580
Classification Product Code
HBI  
Subsequent Product Code
FST  
Date Received07/26/1993
Decision Date 10/28/1993
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
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