FDA.report

510(k) K953968

Device
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)
Applicant
AESCULAP, INC.
510(k) number
K953968
Product code
HWE  
Decision
Substantially Equivalent (SESE)
Decision date
1996-02-05
Date received
1995-08-22
Regulation
878.4820
Classification name
Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Medical specialty
General & Plastic Surgery
Review panel
Orthopedic
Device class
1
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

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FDA Review

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