FDA.report

510(k) K944955

Device
AESCULAP THORACOSCOPIC INSTRUMENTS
Applicant
AESCULAP, INC.
510(k) number
K944955
Product code
KNS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-09
Date received
1994-10-07
Regulation
876.4300
Classification name
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
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
MARY E HOLDEN
Address
1000 Gateway Blvd. South San Francisco CA US 94080 94080

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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