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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 K973656
Device Name DISPOSABLE SILICONE EPISTAXIS CATHETER
Applicant
SPECIALTY SURGICAL PRODUCTS, INC.
302 NORTH FIRST ST.
HAMILTON,  MT  59840
Applicant Contact T. JAN VARNER
Correspondent
SPECIALTY SURGICAL PRODUCTS, INC.
302 NORTH FIRST ST.
HAMILTON,  MT  59840
Correspondent Contact T. JAN VARNER
Regulation Number874.4100
Classification Product Code
EMX  
Date Received09/25/1997
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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