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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, polypropylene
510(k) Number K980703
Device Name PREMILENE NONABSORBABLE POLYPROPYLENE 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 Number878.5010
Classification Product Code
GAW  
Date Received02/23/1998
Decision Date 05/04/1998
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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