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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 K973085
Device Name ULTRACELL PACKING WITH SLEEVE
Applicant
ULTRACELL MEDICAL TECHNOLOGIES, INC.
183 PROVIDENCE,NEW LONDON TNPK
P.O. BOX 326
NORTH STONINGTON,  CT  06359
Applicant Contact GEORGE P KORTEWEG
Correspondent
ULTRACELL MEDICAL TECHNOLOGIES, INC.
183 PROVIDENCE,NEW LONDON TNPK
P.O. BOX 326
NORTH STONINGTON,  CT  06359
Correspondent Contact GEORGE P KORTEWEG
Regulation Number874.4100
Classification Product Code
EMX  
Date Received08/18/1997
Decision Date 11/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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