ENDOXANE— 510(k) K971509

Name: FDA 510(k) clearance K971509
Creator: U.S. Food and Drug Administration
Published: 1997-08-21

Substantially Equivalent - Subject to Tracking Reg.

Novatech SA

FDA 510(k) clearance K971509 for ENDOXANE, Substantially Equivalent - Subject to Tracking Reg. on 1997-08-21. Applicant: Novatech SA. Device class: 2.

Clearance details

Applicant: Novatech SA
Product code: Code NWA
Device class: Class 2
Regulation: 21 CFR 878.3720
Advisory panel: General, Plastic Surgery
Date received: 1997-04-25
Decision date: 1997-08-21
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Aubagne, FR

Download summary PDF View on FDA.gov ↗

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