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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ear Wick
510(k) Number K791059
Device Name POPE OTO-WICK, STERILE & NON-STERILE
Applicant
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Correspondent
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Regulation Number874.5220
Classification Product Code
KCN  
Date Received06/08/1979
Decision Date 07/17/1979
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
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