SUTURE RETENTION DEVICE— 510(k) K883299

Name: FDA 510(k) clearance K883299
Creator: U.S. Food and Drug Administration
Published: 1988-08-23

Substantially Equivalent

Edwards Orthopaedics Div., Baxter Healthcare Corp.

FDA 510(k) clearance K883299 for SUTURE RETENTION DEVICE, Substantially Equivalent on 1988-08-23. Applicant: Edwards Orthopaedics Div., Baxter Healthcare Corp.. Device class: 1.

Clearance details

Applicant: Edwards Orthopaedics Div., Baxter Healthcare Corp.
Product code: Code KGS
Device class: Class 1
Regulation: 21 CFR 878.4930
Advisory panel: General, Plastic Surgery
Date received: 1988-08-04
Decision date: 1988-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.