FDA.report

510(k) K964281

Device
Aesculap Angled Neuroendoscopes
Applicant
AESCULAP, INC.
510(k) number
K964281
Product code
GWG
Decision
Substantially Equivalent (SESE)
Decision date
1997-04-21
Date received
1996-10-28
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MARY ELLEN 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

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