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510(k) K901154

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

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.

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  • 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)

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  • K081698 — MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (July 30, 2008)
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  • K051505 — SCB/STERIS OR-LIGHT INTERFACE BOX (August 11, 2005)
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