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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name polymer, ent synthetic, porous polyethylene
510(k) Number K771727
Device Name BIOSPONGE RECONSTRUCTION DISCS
Applicant
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Correspondent
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Regulation Number874.3620
Classification Product Code
JOF  
Date Received09/13/1977
Decision Date 09/26/1977
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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