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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 K971411
Device Name DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K
Applicant
Bentec Medical, Inc.
4234 N. Fwy. Blvd.
Sacramento,  CA  95834
Applicant Contact LOU MATSON
Correspondent
Bentec Medical, Inc.
4234 N. Fwy. Blvd.
Sacramento,  CA  95834
Correspondent Contact LOU MATSON
Regulation Number874.4100
Classification Product Code
EMX  
Date Received04/16/1997
Decision Date 06/03/1997
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
Predetermined Change
Control Plan Authorized		 No
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