Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene
510(k) Number K180321
Device Name Aesculap Optilene Nonabsorbable Suture
Applicant
Aesculap, Inc.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact Kathy A. Racosky
Correspondent
Aesculap, Inc.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact Kathy A. Racosky
Regulation Number878.5010
Classification Product Code
GAW  
Date Received02/05/2018
Decision Date 03/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-