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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 K012201
Device Name PREMICRON NONABSORBABLE PET SURGICAL SUTURE
Applicant
AESCULAP, INC.
13221 MARICOTTE PLACE
SAN DIEGO,  CA  92130
Applicant Contact STEVE REITZLER
Correspondent
AESCULAP, INC.
13221 MARICOTTE PLACE
SAN DIEGO,  CA  92130
Correspondent Contact STEVE REITZLER
Regulation Number878.5000
Classification Product Code
GAT  
Date Received07/13/2001
Decision Date 09/19/2001
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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