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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar, Sinus
510(k) Number K844186
Device Name CONTINENT STOMA SYSTEM & ACCESSORIES
Applicant
Chesebrough-Pond'S U.S.A. Co.
P.O. Box 6000
Greenwich,  CT  06836
Applicant Contact ARNOLD I FRIEDE
Correspondent
Chesebrough-Pond'S U.S.A. Co.
P.O. Box 6000
Greenwich,  CT  06836
Correspondent Contact ARNOLD I FRIEDE
Regulation Number874.4420
Classification Product Code
KBG  
Date Received10/29/1984
Decision Date 01/15/1985
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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