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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 K051911
Device Name GELITA-SPON
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 Received07/14/2005
Decision Date 12/06/2005
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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