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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 K935724
Device Name THE EXPANDACELL SINUS PACK
Applicant
DENVER SPLINT CO.
7002 SOUTH REVERE PARKWAY,
SUITE 60
ENGLEWOOD,  CO  80112
Applicant Contact SARAH M LAKE
Correspondent
DENVER SPLINT CO.
7002 SOUTH REVERE PARKWAY,
SUITE 60
ENGLEWOOD,  CO  80112
Correspondent Contact SARAH M LAKE
Regulation Number874.4100
Classification Product Code
EMX  
Date Received12/01/1993
Decision Date 05/12/1994
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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