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510(k) K820681

CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT by Sybron Corp. — Product Code FSY

K820681 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT". The FDA issued a decision of Substantially Equivalent on April 15, 1982. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Sybron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1982
Date Received
March 11, 1982
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 Sybron Corp.

  • K862284 — SEALITE (June 23, 1986)
  • K854855 — PROOF ALGINATE IMPRESSION MATERIAL (January 30, 1986)
  • K844092 — DIAGNOSTIC MICROSOPCE SLIDES (October 25, 1984)
  • K842132 — TYCOS SELF-CHECK/DIGITAL FEVER THERMO (July 18, 1984)
  • K841910 — KERR SEALAPEX ROOT CANAL SEALER (July 13, 1984)
  • K841732 — LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM (June 5, 1984)
  • K840469 — TYCOS SELF CHECK BPM3 BLOOD PRESS MONI (May 21, 1984)
  • K840407 — KERR RESIN BONDED BRIDGE CEMENT (May 21, 1984)
  • K840607 — LF MOTORIZED RADIOGRAPHIC FILM VIEWER (March 5, 1984)
  • K833138 — DIGITAL INJECTOR SYS (November 14, 1983)

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)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K140460 — MACH LED 2SC (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