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510(k) K914076

MDT/CASTLE 2000 SURGICAL LIGHTS by Mdt Corp., Inc. — Product Code FSY

K914076 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "MDT/CASTLE 2000 SURGICAL LIGHTS". The FDA issued a decision of Substantially Equivalent on November 13, 1991. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Mdt Corp., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1991
Date Received
September 11, 1991
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 Mdt Corp., Inc.

  • K960777 — MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR (May 23, 1996)
  • K942485 — MDT UROLOGY TABLE (August 26, 1994)
  • K942486 — IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE (August 10, 1994)
  • K924380 — MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE (February 16, 1994)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • K924955 — MDT/HARVEY MC-8 AND MC-10 (October 15, 1993)
  • K932094 — BOVIE ULTRASONIC SURGICAL ASPIRATOR (July 21, 1993)
  • K931169 — MDT DENTAL CHAIR (May 20, 1993)
  • K920930 — MDT/CASTLE 10/90 DUAL LOAD STATION (March 31, 1993)
  • K922212 — MDT CASTLE BIOSIGN TEST PACK (August 10, 1992)

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