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510(k) K900376

HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) by Pmt Corp. — Product Code FSM

K900376 is an FDA 510(k) premarket notification submitted by Pmt Corp. for the device "HAND SURGERY AND IRRIGATION TRAY (MODEL 3625)". The FDA issued a decision of Substantially Equivalent on April 10, 1990. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Pmt Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1990
Date Received
January 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Pmt Corp.

  • K122376 — PMT TRUSCAN SURFACE ELECTRODE (December 19, 2012)
  • K090733 — PMT HALO SYSTEM (July 28, 2009)
  • K082474 — PMT SUBDURAL CORTICAL ELECTRODES (May 8, 2009)
  • K042901 — ENDOMARK STERILE INDIA INK (March 16, 2005)
  • K033730 — PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES (August 3, 2004)
  • K972597 — PMT NEW BEGINNINGS GELSHAPES & AMEND (October 1, 1997)
  • K970418 — PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) (April 29, 1997)
  • K964224 — STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTR (March 19, 1997)
  • K935560 — PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) (November 7, 1994)
  • K933079 — ELECTROCAUTERY SYSTEM MODEL 1980 (February 22, 1994)

Other clearances for product code FSM

  • K971217 — INSTRUMENT TRAY LINER (May 6, 1997)
  • K962328 — SINGLE USE INSTRUMENT TRAY (August 9, 1996)
  • K944025 — SURGICAL INSTRUMENT TRAY (November 22, 1994)
  • K912106 — ARTHROSCOPY TRAY (August 29, 1991)
  • K912053 — OPEN HEART TRAY (August 26, 1991)
  • K912052 — HEART CATH TRAY (August 20, 1991)
  • K912104 — MAJOR BASIN TRAY (August 9, 1991)
  • K910570 — SPLINTER TWEEZERS (May 31, 1991)
  • K911601 — REDDICK TROCAR AND CANNULA (May 21, 1991)
  • K910328 — KEY COMFORT GRIPS (March 6, 1991)

FDA data resources