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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 K912524
Device Name EXPANDACEL NASAL TAMPONS, MODIFICATION
Applicant
SURGITREND, LTD.
6099 SOUTH QUEBEC ST. #200
ENGLEWOOD,  CO  80111
Applicant Contact RON SHIPPERET
Correspondent
SURGITREND, LTD.
6099 SOUTH QUEBEC ST. #200
ENGLEWOOD,  CO  80111
Correspondent Contact RON SHIPPERET
Regulation Number874.4100
Classification Product Code
EMX  
Date Received06/03/1991
Decision Date 08/15/1991
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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