FDA.report

510(k) K971310

Device
Aesculap Jet Irrigation System
Applicant
AESCULAP, INC.
510(k) number
K971310
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
1997-07-18
Date received
1997-04-08
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
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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