FDA.report

510(k) K972332

Device
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
Applicant
AESCULAP, INC.
510(k) number
K972332
Product code
GXN  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-16
Date received
1997-06-23
Regulation
882.5330
Classification name
Plate, Cranioplasty, Preformed, Non-alterable
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 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

Legacy Summary

summary

FDA Review

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