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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K955560
Device Name TREBAY SCOPE IRRIGATED CLEARING SLEEVE
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 Number874.4760
Classification Product Code
EOB  
Date Received12/06/1995
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
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