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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K982594
Device Name ENDO-SCRUB/ENDO-SCRUB 2
Applicant
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Applicant Contact DEBRA B CORTNER
Correspondent
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Correspondent Contact DEBRA B CORTNER
Regulation Number874.4760
Classification Product Code
EOB  
Date Received07/24/1998
Decision Date 08/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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