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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K082535
Device Name COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
Applicant
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN
60 Middletown Ave
North Haven,  CT  06473
Applicant Contact TIM M LOHNES
Correspondent
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN
60 Middletown Ave
North Haven,  CT  06473
Correspondent Contact TIM M LOHNES
Regulation Number878.5000
Classification Product Code
GAT  
Date Received09/02/2008
Decision Date 12/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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