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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K831589
Device Name VENT TUBE FORCEPS
Applicant
Treace Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Treace Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number874.4350
Classification Product Code
EQH  
Date Received05/17/1983
Decision Date 06/16/1983
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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