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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 K900171
Device Name EXPANDACEL NASAL TAMPONS
Applicant
Surgitrend, Ltd.
6099 S. Quebec St. #200
Englewood,  CO  80111
Applicant Contact SHIPPERT, MD
Correspondent
Surgitrend, Ltd.
6099 S. Quebec St. #200
Englewood,  CO  80111
Correspondent Contact SHIPPERT, MD
Regulation Number874.4100
Classification Product Code
EMX  
Date Received01/12/1990
Decision Date 06/14/1990
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
Predetermined Change
Control Plan Authorized		 No
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