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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-polyamide (mesh or foil material)
510(k) Number K060878
Device Name GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
Applicant
CURAMEDICAL, BV
220 RIVER ROAD
CLAREMONT,  NH  03743
Applicant Contact WILLIAM GREENROSE
Correspondent
CURAMEDICAL, BV
220 RIVER ROAD
CLAREMONT,  NH  03743
Correspondent Contact WILLIAM GREENROSE
Regulation Number874.3620
Classification Product Code
KHJ  
Subsequent Product Code
LYA  
Date Received03/31/2006
Decision Date 04/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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