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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer, ear, nose and throat, synthetic, absorbable
510(k) Number K012769
Device Name MACROPORE ENT RECONSTRUCTION FILM
Applicant
MACROPORE BIOSURGERY, INC.
6740 TOP GUN ST.
SAN DIEGO,  CA  92121
Applicant Contact KENNETH K KLEINHENZ
Correspondent
MACROPORE BIOSURGERY, INC.
6740 TOP GUN ST.
SAN DIEGO,  CA  92121
Correspondent Contact KENNETH K KLEINHENZ
Regulation Number874.3620
Classification Product Code
NHB  
Subsequent Product Code
LYA  
Date Received08/17/2001
Decision Date 10/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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