RACESTYPTINE— 510(k) K884653

Substantially Equivalent

Specialites Septodont

FDA 510(k) clearance K884653 for RACESTYPTINE, Substantially Equivalent on 1989-01-19. Applicant: Specialites Septodont. Device class: 1.

Clearance details

Applicant: Specialites Septodont
Product code: Code EKJ
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1988-11-07
Decision date: 1989-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKJ

K961714 — ASEPTYLUM, UNI-CARRIER1996-06-10
K953707 — MEDTROL DENTAL KIT1996-01-04
K945815 — DENTAL KIT1995-07-19
K951607 — SUREFLEX FILES1995-06-22
K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL1994-11-30

More clearances from Specialites Septodont

K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT2001-10-09
K010415 — ISODAN2001-07-23
K982773 — QUICKSET LIQUID AND POWDER1998-11-03
K982671 — SECURALLOY1998-10-19
K980633 — ENDOSOLV E1998-05-01

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