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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 K955593
Device Name EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY
Applicant
SHIPPERT MEDICAL TECHNOLOGIES CORP.
7002 SOUTH REVERE PARKWAY,
SUITE 60
ENGLEWOOD,  CO  80112
Applicant Contact SARAH LAKE
Correspondent
SHIPPERT MEDICAL TECHNOLOGIES CORP.
7002 SOUTH REVERE PARKWAY,
SUITE 60
ENGLEWOOD,  CO  80112
Correspondent Contact SARAH LAKE
Regulation Number874.4100
Classification Product Code
EMX  
Date Received12/07/1995
Decision Date 12/22/1995
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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