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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K945659
Device Name BLACKSTAR(TM) STAR SYSTEM
Applicant
Xomed-Treace, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent
Xomed-Treace, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Regulation Number874.4250
Classification Product Code
ERL  
Date Received11/17/1994
Decision Date 01/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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