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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 K990088
Device Name SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE
Applicant
AESCULAP, INC.
ONE AMERICA PLAZA, SUITE 900
600 WEST BROADWAY
SAN DIEGO,  CA  92101 -3302
Applicant Contact STEVE REITZLER
Correspondent
AESCULAP, INC.
ONE AMERICA PLAZA, SUITE 900
600 WEST BROADWAY
SAN DIEGO,  CA  92101 -3302
Correspondent Contact STEVE REITZLER
Regulation Number878.5000
Classification Product Code
GAT  
Date Received01/11/1999
Decision Date 02/10/1999
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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