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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 K945554
Device Name EPISTAXIS BALLOON CATHETER WITH PACKING
Applicant
ULTRACELL MEDICAL TECHNOLOGIES, INC.
POST OFFICE BOX 609
OLD MYSTIC,  CT  06372
Applicant Contact GEORGE P KORTEWEG
Correspondent
ULTRACELL MEDICAL TECHNOLOGIES, INC.
POST OFFICE BOX 609
OLD MYSTIC,  CT  06372
Correspondent Contact GEORGE P KORTEWEG
Regulation Number874.4100
Classification Product Code
EMX  
Date Received11/14/1994
Decision Date 02/17/1995
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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