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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 K974174
Device Name ULTRABUR
Applicant
MEDNET LOCATOR, INC.
7000 SHADOW OAKS
MEMPHIS,  TN  38125
Applicant Contact JUDY CHANDLEER
Correspondent
MEDNET LOCATOR, INC.
7000 SHADOW OAKS
MEMPHIS,  TN  38125
Correspondent Contact JUDY CHANDLEER
Regulation Number874.4250
Classification Product Code
ERL  
Date Received11/06/1997
Decision Date 03/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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