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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name retractor
510(k) Number K915158
Device Name SUREBREATH DOME, E-Z BREATHER
Applicant
IPAX, INC.
2109 WEST AMHERST AVE.
ENGLEWOOD,  CO  80110
Applicant Contact PHILLIP PENNELL
Correspondent
IPAX, INC.
2109 WEST AMHERST AVE.
ENGLEWOOD,  CO  80110
Correspondent Contact PHILLIP PENNELL
Regulation Number878.4800
Classification Product Code
GAD  
Date Received11/14/1991
Decision Date 02/12/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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