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510(k) K790491

ITIMIZED INSTRUMENTS by E.M. Adams — Product Code FZT

K790491 is an FDA 510(k) premarket notification submitted by E.M. Adams for the device "ITIMIZED INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on April 4, 1979. The device falls under product code FZT (Cutter, Surgical), a Class I device regulated under 21 CFR 878.4800. E.M. Adams has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1979
Date Received
March 8, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by E.M. Adams

  • K905173 — SPLASH GUARD (April 25, 1991)
  • K910468 — STERILE DISPOSABLE DRAPE(S) (March 21, 1991)
  • K873978 — DISPOSABLE BIPOLAR FORCEPS (November 23, 1987)
  • K850063 — INSTRUMENT POCKET (February 21, 1985)
  • K843724 — I.V. START KIT & OBSTETRICAL KIT (January 10, 1985)
  • K843783 — WET PACK (December 19, 1984)
  • K843782 — DRY TRAY (December 13, 1984)
  • K843723 — STERILE INSTRUMENT TRAYS-VARIOUS (October 23, 1984)
  • K843115 — STERILE SOLUTION BOWL (September 7, 1984)
  • K843116 — DISPOSABLE SKIN MARKING PEN (August 17, 1984)

Other clearances for product code FZT

  • K112400 — SMARTSHEARS (September 12, 2011)
  • K890818 — AUTO SUTURE DISPOSABLE SURGICAL TROCAR* (May 4, 1989)
  • K872990 — MICRINS SURGICAL SCISSOR (August 17, 1987)
  • K841741 — SINGLE HAIR TRANSPLANT GRAFT (July 23, 1984)
  • K841247 — SPC DISPOSABLE CUTTER (May 2, 1984)
  • K822448 — SCISSORS, VARIOUS (September 14, 1982)
  • K821632 — SURGICAL SCISSORS, SET OF 3 (June 24, 1982)
  • K821350 — CONPHAR WIRE CUTTING SCISSORS (May 27, 1982)
  • K821361 — CONPHAR TONSIL SCISSORS (May 27, 1982)
  • K821352 — CONPHAR IRIS SCISSORS (May 27, 1982)

FDA data resources