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510(k) K831119

LUO CURRETTES #3211 by Pmt, Inc. — Product Code FZS

K831119 is an FDA 510(k) premarket notification submitted by Pmt, Inc. for the device "LUO CURRETTES #3211". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code FZS (Curette, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Pmt, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
April 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Pmt, Inc.

  • 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 FZS

  • K932493 — SURGICAL CURETTE (January 7, 1994)
  • K902000 — KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD (August 21, 1990)
  • K892521 — CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE (May 1, 1989)
  • K891888 — CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER (April 12, 1989)
  • K891334 — ACU-CURETTE (April 11, 1989)
  • K890366 — ADENOID CURETTE (February 3, 1989)
  • K875292 — MICRODISCECTOMY CURETTE SET (January 29, 1988)
  • K871925 — STRAIGHT CUP CURRETTE, 1.7MM (June 1, 1987)
  • K854899 — NOVAK CURETTE (December 24, 1985)
  • K854888 — RANDALL CURETTE (December 24, 1985)

FDA data resources