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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K014100
Device Name OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
Applicant
OPUSDENT LTD.
117 AHUZAH ST.
RA'ANANNA,  IL
Applicant Contact ARAVA HACOHEN
Correspondent
OPUSDENT LTD.
117 AHUZAH ST.
RA'ANANNA,  IL
Correspondent Contact ARAVA HACOHEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/13/2001
Decision Date 01/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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