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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 K102639
Device Name SL3
Applicant
DISCUS DENTAL, LLC
8550 HIGUERA ST.
CULVER CITY,  CA  90232
Applicant Contact CLARK D VONAHSEN
Correspondent
DISCUS DENTAL, LLC
8550 HIGUERA ST.
CULVER CITY,  CA  90232
Correspondent Contact CLARK D VONAHSEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/14/2010
Decision Date 12/01/2010
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
Recalls CDRH Recalls
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