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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 K933672
Device Name XOMED-TREACE SCOPESHEATH
Applicant
Xomed-Treace, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact TERRY C MCMAHON
Correspondent
Xomed-Treace, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent Contact TERRY C MCMAHON
Regulation Number874.4760
Classification Product Code
EOB  
Date Received07/28/1993
Decision Date 07/18/1994
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
Predetermined Change
Control Plan Authorized		 No
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