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510(k) K872480

KAHN-TACT U.S.A., EFF LARYNGOSCOPE by Effner and Spreine Co. — Product Code CCW

K872480 is an FDA 510(k) premarket notification submitted by Effner and Spreine Co. for the device "KAHN-TACT U.S.A., EFF LARYNGOSCOPE". The FDA issued a decision of Substantially Equivalent on August 10, 1987. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Effner and Spreine Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1987
Date Received
June 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Rigid
Device Class
Class I
Regulation Number
868.5540
Review Panel
AN
Submission Type

Other clearances by Effner and Spreine Co.

  • K875260 — EFFNER CAUTERY INSTRUMENTS (June 6, 1988)
  • K874755 — EFFNER FE-EX* OROGASTRIC (April 6, 1988)
  • K852014 — EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA (August 7, 1985)

Other clearances for product code CCW

  • K191602 — APA Oxy Blade (August 2, 2019)
  • K163412 — Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) (June 22, 2017)
  • K140951 — YEESCOPE LARYNGOSCOPES (November 10, 2014)
  • K121378 — AIRTRAQ SP AIRTRAQ AVANT (June 21, 2012)
  • K063477 — NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET (February 9, 2007)
  • K062523 — TRU-MR LARYNGOSCOPE SET (November 17, 2006)
  • K062231 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (August 31, 2006)
  • K062230 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (August 31, 2006)
  • K041852 — MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (November 15, 2004)
  • K984101 — FLEXIBLADE (September 3, 1999)

FDA data resources