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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Recombinant Technology
510(k) Number K100876
Device Name AESCULAP MONOMAX ABSORBABLE SUTURE
Applicant
Aesculap, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact KATHY A RACOSKY
Correspondent
Aesculap, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact KATHY A RACOSKY
Regulation Number878.4494
Classification Product Code
NWJ  
Date Received03/30/2010
Decision Date 07/14/2010
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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