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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K140064
Device Name SURGISLEEVE WOUND PROTECTOR
Applicant
Covidien
60 Middletown Dr.
North Haven,  CT  06473
Applicant Contact MICHAEL KOCZOCIK
Correspondent
Covidien
60 Middletown Dr.
North Haven,  CT  06473
Correspondent Contact MICHAEL KOCZOCIK
Regulation Number878.4370
Classification Product Code
KKX  
Subsequent Product Code
GCJ  
Date Received01/10/2014
Decision Date 03/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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