FDA.report

510(k) K170661

Device
Novosyn Quick Absorbable Suture
Applicant
Aesculap, Inc.
510(k) number
K170661
Product code
GAM  
Decision
Substantially Equivalent (SESE)
Decision date
2017-06-08
Date received
2017-03-03
Regulation
878.4493
Classification name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Kathy A. Racosky
Address
3773 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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