Home / 510(k) Clearances / K800089

510(k) K800089

CRAWFORD LACRIMAL INTUBATION SET by Jedmed Instrument Co. — Product Code HNL

K800089 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "CRAWFORD LACRIMAL INTUBATION SET". The FDA issued a decision of Substantially Equivalent on March 3, 1980. The device falls under product code HNL (Probe, Lachrymal), a Class I device regulated under 21 CFR 886.4350. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1980
Date Received
January 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Lachrymal
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Jedmed Instrument Co.

  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (February 21, 2014)
  • K021750 — LID CHAIN EYELID WEIGHTS (January 27, 2003)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K944032 — VIDEO SCOPE SYSTEM (LARYNGOSCOPE) (September 15, 1995)
  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K950925 — JEDMED LARYNGEAL SCOPE (August 11, 1995)
  • K950785 — HORTMANN AIRMATIC AIR CALORIC STIMULATOR (June 28, 1995)
  • K950078 — MICROFLOW IRRIGATION SYSTEM (June 21, 1995)
  • K944671 — VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) (February 7, 1995)

Other clearances for product code HNL

  • K843491 — CONCEPT FIBER OPTIC CANALICULUS INTUBA (October 5, 1984)
  • K840861 — TSE-ANDERSON MODIFIED LACRIMAL GROOV (May 9, 1984)
  • K833671 — STERILE OIL AND GUIDEWIRE (January 10, 1984)
  • K831901 — LACIMAL INTUBATION SETS (July 12, 1983)
  • K813187 — PILLING LACRIMAL INTUBATION SYSTEM (January 28, 1982)
  • K812255 — ETHICON LACRIMAL STENT (August 20, 1981)
  • K802845 — CONCEPT CANALICULUS INTUBATION SET (December 17, 1980)
  • K801232 — JACKSON LACRIMAL INTUBATION SET (June 17, 1980)
  • K770194 — NASO-LACRIMAL DUCT INSERT (February 14, 1977)

FDA data resources