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510(k) K901154

MICROTEK'S SURGICAL LAMP HANDLE & COVER by Microbio-Medics, Inc. — Product Code FTA

K901154 is an FDA 510(k) premarket notification submitted by Microbio-Medics, Inc. for the device "MICROTEK'S SURGICAL LAMP HANDLE & COVER". The FDA issued a decision of Substantially Equivalent on March 20, 1990. The device falls under product code FTA (Light, Surgical, Accessories), a Class II device regulated under 21 CFR 878.4580. Microbio-Medics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1990
Date Received
March 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Microbio-Medics, Inc.

  • K923353 — VENTILATION TUBES W/ HYDROGEL COATING (May 18, 1993)
  • K922572 — 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR (November 2, 1992)
  • K913276 — MICROTEK MEDICAL'S SOUND STIKS (October 21, 1991)
  • K904239 — SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES (June 21, 1991)
  • K910167 — MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM (April 15, 1991)
  • K900726 — MICROTEK MEDICAL'S BLOOD COLLECTION KIT (May 4, 1990)
  • K895814 — MICROTEK PISTON & WIRE PROSTHESES (December 26, 1989)
  • K895815 — MICROTEK TOTAL OSSICULAR PROTHESIS (December 26, 1989)
  • K895502 — MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT (December 8, 1989)
  • K885201 — OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT (April 19, 1989)

Other clearances for product code FTA

  • K150532 — Universal Light Handle Cover, Light Handle Cover (September 22, 2015)
  • K142386 — Operating Room Light Handle Adapter (September 29, 2014)
  • K133554 — SURGICAL LIGHT HANDLE COVER (April 8, 2014)
  • K133413 — IDSS SLC (January 7, 2014)
  • K112133 — OASYS SURGICAL LIGHT CONTROLLER (March 1, 2012)
  • K102791 — EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (November 23, 2010)
  • K081698 — MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (July 30, 2008)
  • K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (January 19, 2006)
  • K051505 — SCB/STERIS OR-LIGHT INTERFACE BOX (August 11, 2005)
  • K023704 — KSEA SCB ACC CONTROL (January 30, 2003)

FDA data resources