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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transilluminator, Ac-Powered
510(k) Number K933445
Device Name DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)
Applicant
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Applicant Contact MICHAEL H SOUTHWORTH
Correspondent
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Correspondent Contact MICHAEL H SOUTHWORTH
Regulation Number886.1945
Classification Product Code
HJM  
Date Received07/13/1993
Decision Date 09/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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