RESTORE-X— 510(k) K011520

Substantially Equivalent

First Scientific Limited

FDA 510(k) clearance K011520 for RESTORE-X, Substantially Equivalent on 2001-07-23. Applicant: First Scientific Limited. Device class: 2.

Clearance details

Applicant: First Scientific Limited
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2001-05-17
Decision date: 2001-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blaenau Gwent, Wales, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

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More clearances from First Scientific Limited

K011521 — ORTHO VLC; ORTHO VLC CAPSULE2001-08-01
K011517 — LUTE; CORE2001-07-10
K011295 — RESTORE-PF VIC; RESTORE-PF VLC CAPSULE2001-06-27
K011309 — LUTE VLC; CORE VLC2001-06-22

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