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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 K112505
Device Name ETHEREA
Applicant
REGULATORY INSIGHT, INC.
5401 S.COTTONWOOD COURT
GREENWOOD VILLAGE,  CO  80121
Applicant Contact Kevin Walls
Correspondent
REGULATORY INSIGHT, INC.
5401 S.COTTONWOOD COURT
GREENWOOD VILLAGE,  CO  80121
Correspondent Contact Kevin Walls
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ILY   ONF  
Date Received08/30/2011
Decision Date 04/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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