FDA.report

510(k) K203461

Device
Aesculap Caiman 12 Seal And Cut Technology System
Applicant
Aesculap Inc.
510(k) number
K203461
Product code
GEI  
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-18
Date received
2020-11-24
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Omunique Luke
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

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FDA Review

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