SURGICAL LIGHTING-CENTRA 450— 510(k) K902864

Name: FDA 510(k) clearance K902864
Creator: U.S. Food and Drug Administration
Published: 1990-09-10

Substantially Equivalent

Sds Dental, Inc.

FDA 510(k) clearance K902864 for SURGICAL LIGHTING-CENTRA 450, Substantially Equivalent on 1990-09-10. Applicant: Sds Dental, Inc.. Device class: 2.

Clearance details

Applicant: Sds Dental, Inc.
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1990-06-29
Decision date: 1990-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSY

view all

K142984 — Leo Minor2014-10-29
K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT2014-09-30
K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT2014-08-07
K132551 — ZF 7202014-06-30
K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES2014-06-09

More clearances from Sds Dental, Inc.

view all

K990546 — DELSONIC 20001999-11-05
K990545 — JETSONIC 20001999-08-11
K964619 — DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)1997-01-22
K902865 — BAUMER SURGICAL TABLE1990-09-10
K863011 — DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II1986-10-10

Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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