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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 K933105
Device Name XOMED-TREACE RIGID ROD LENS ENDOSCOPE
Applicant
XOMED-TREACE, INC.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE,  FL  32216 -0980
Applicant Contact TERRY MCMAHON
Correspondent
XOMED-TREACE, INC.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE,  FL  32216 -0980
Correspondent Contact TERRY MCMAHON
Regulation Number874.4760
Classification Product Code
EOB  
Date Received06/25/1993
Decision Date 01/05/1994
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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