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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K923830
Device Name XOMED-TREACE ALPHASCOPE
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 Number874.4770
Classification Product Code
ERA  
Date Received07/31/1992
Decision Date 11/09/1992
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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