THERMALASTIC/TRIPOLYVINALENE— 510(k) K954662

Substantially Equivalent

Tak Systems

FDA 510(k) clearance K954662 for THERMALASTIC/TRIPOLYVINALENE, Substantially Equivalent on 1995-11-15. Applicant: Tak Systems. Device class: 2.

Clearance details

Applicant
Tak Systems
Product code
Code ELW
Device class
Class 2
Regulation
21 CFR 872.3660
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wareham, MA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code ELW

view all

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