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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, absorbable, synthetic, polyglycolic acid
510(k) Number K122734
Device Name AESCULAP NOVOSYN ABSORBABLE SUTURE
Original Applicant
AESCULAP, INC.
3773 corporate parkway
center valley,  PA  18034
Original Contact kathy a racosky
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/06/2012
Decision Date 12/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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