FDA.report

510(k) K954652

Device
AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS
Applicant
AESCULAP, INC.
510(k) number
K954652
Product code
HRX  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1996-02-14
Date received
1995-10-10
Regulation
888.1100
Classification name
Arthroscope
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No
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 not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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