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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name resin, denture, relining, repairing, rebasing
510(k) Number K082180
Device Name PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440
Applicant
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS
11234 EL CAMINO REAL,
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact LINDA K SCHULZ
Correspondent
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS
11234 EL CAMINO REAL,
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact LINDA K SCHULZ
Regulation Number872.3760
Classification Product Code
EBI  
Date Received08/01/2008
Decision Date 12/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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