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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Ear, Nose And Throat
510(k) Number K955294
Device Name SOF - ABRASION BUR
Applicant
TREBAY MEDICAL CORP.
4911 CREEKSIDE DR.
CLEARWATER,  FL  34620
Applicant Contact DAN H TREACE
Correspondent
TREBAY MEDICAL CORP.
4911 CREEKSIDE DR.
CLEARWATER,  FL  34620
Correspondent Contact DAN H TREACE
Regulation Number874.4140
Classification Product Code
EQJ  
Date Received11/17/1995
Decision Date 12/22/1995
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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