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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name balloon, epistaxis
510(k) Number K921199
Device Name EPISTAXIS NASAL BALLOON CATHETER
Applicant
SMITH & NEPHEW RICHARDS, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact THOMAS CRAIG
Correspondent
SMITH & NEPHEW RICHARDS, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact THOMAS CRAIG
Regulation Number874.4100
Classification Product Code
EMX  
Date Received03/12/1992
Decision Date 07/08/1992
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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