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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ent Manual Surgical
510(k) Number K942064
Device Name DISPOSABLE NASAL RONGEUR
Applicant
United States Surgical, A Division Of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact DEBORAH ROCKAFELLOW
Correspondent
United States Surgical, A Division Of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact DEBORAH ROCKAFELLOW
Regulation Number874.4420
Classification Product Code
LRC  
Date Received04/29/1994
Decision Date 06/08/1994
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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