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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, shunt, endolymphatic
510(k) Number K952227
Device Name C-FLEX ENDOLYMPHATIC SHUNT
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 Number874.3820
Classification Product Code
ESZ  
Date Received05/12/1995
Decision Date 06/16/1995
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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