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510(k) K852994

REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 by Reichert-Jung, Inc. — Product Code CAL

K852994 is an FDA 510(k) premarket notification submitted by Reichert-Jung, Inc. for the device "REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11". The FDA issued a decision of Substantially Equivalent on July 29, 1985. The device falls under product code CAL (Laryngoscope, Non-Rigid), a Class I device regulated under 21 CFR 868.5530. Reichert-Jung, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1985
Date Received
July 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Non-Rigid
Device Class
Class I
Regulation Number
868.5530
Review Panel
AN
Submission Type

Other clearances by Reichert-Jung, Inc.

  • K864821 — AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2 (February 10, 1987)
  • K862551 — FUNS-10, FUNS-11 (September 12, 1986)

Other clearances for product code CAL

  • K951195 — FI-10P (April 6, 1995)
  • K951194 — FI-10M (April 6, 1995)
  • K872895 — HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. (January 11, 1988)
  • K850978 — OLYMPUS LF-1 INTUBATION SCOPE (May 23, 1985)
  • K802331 — AO FLEXIBLE LARYNGOSCOPE, #LS-7 (October 10, 1980)
  • K801364 — AO STYLET LARYNGOSCOPE MODEL SLS (June 17, 1980)
  • K791634 — AO STYLET LARYNGOSCOPE, MODEL SLS-1 (September 17, 1979)

FDA data resources