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510(k) K902864

SURGICAL LIGHTING-CENTRA 450 by Sds Dental, Inc. — Product Code FSY

K902864 is an FDA 510(k) premarket notification submitted by Sds Dental, Inc. for the device "SURGICAL LIGHTING-CENTRA 450". The FDA issued a decision of Substantially Equivalent on September 10, 1990. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Sds Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1990
Date Received
June 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Sds Dental, Inc.

  • K990546 — DELSONIC 2000 (November 5, 1999)
  • K990545 — JETSONIC 2000 (August 11, 1999)
  • K964619 — DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) (January 22, 1997)
  • K902865 — BAUMER SURGICAL TABLE (September 10, 1990)
  • K863011 — DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II (October 10, 1986)
  • K863016 — DENTATUS L SET (October 1, 1986)
  • K863013 — ISOLAX PEDAL SET (October 1, 1986)
  • K863012 — MINILAX SET (October 1, 1986)
  • K863021 — CM-II, CM-I WATER UNIT (October 1, 1986)
  • K863015 — ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT (October 1, 1986)

Other clearances for product code FSY

  • K142984 — Leo Minor (October 29, 2014)
  • K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT (September 30, 2014)
  • K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (August 7, 2014)
  • K132551 — ZF 720 (June 30, 2014)
  • K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (June 9, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)

FDA data resources