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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 K954912
Device Name TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)
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 Received10/23/1995
Decision Date 12/06/1995
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
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