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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K031216
Device Name MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
Applicant
Aesculap
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact GEORG KELLER
Correspondent
Aesculap
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact GEORG KELLER
Regulation Number878.4840
Classification Product Code
NEW  
Date Received04/17/2003
Decision Date 07/17/2003
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
Predetermined Change
Control Plan Authorized		 No
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