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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Forceps, Biopsy, Bronchoscope (Non-Rigid)
510(k) Number K843282
Device Name UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC
Applicant
RUSH HAMPTON INDUSTRIES
P.O. BOX 5500
SANFORD,  FL  32772
Applicant Contact STEPHEN E FRAZIER
Correspondent
RUSH HAMPTON INDUSTRIES
P.O. BOX 5500
SANFORD,  FL  32772
Correspondent Contact STEPHEN E FRAZIER
Regulation Number874.4680
Classification Product Code
BWH  
Date Received08/20/1984
Decision Date 10/22/1984
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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