FDA.report

510(k) K983365

Device
AESCULAP MINOP SYSTEM
Applicant
AESCULAP, INC.
510(k) number
K983365
Product code
GWG  
Decision
Substantially Equivalent (SESE)
Decision date
1998-12-18
Date received
1998-09-24
Regulation
882.1480
Classification name
Endoscope, Neurological
Medical specialty
Neurology
Review panel
Neurology
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

summary

FDA Review

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