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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 K120926
Device Name ENDOBEAM HOLMIUM LASER FIBERS
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON,  GA  30209
Applicant Contact TERRI MORRIS
Correspondent
C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON,  GA  30209
Correspondent Contact TERRI MORRIS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/27/2012
Decision Date 07/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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