Home / 510(k) Clearances / K840861

510(k) K840861

TSE-ANDERSON MODIFIED LACRIMAL GROOV by Hansen Ophthalmic Development Lab — Product Code HNL

K840861 is an FDA 510(k) premarket notification submitted by Hansen Ophthalmic Development Lab for the device "TSE-ANDERSON MODIFIED LACRIMAL GROOV". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code HNL (Probe, Lachrymal), a Class I device regulated under 21 CFR 886.4350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
February 24, 1984
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 for product code HNL

  • K843491 — CONCEPT FIBER OPTIC CANALICULUS INTUBA (October 5, 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)
  • K800089 — CRAWFORD LACRIMAL INTUBATION SET (March 3, 1980)
  • K770194 — NASO-LACRIMAL DUCT INSERT (February 14, 1977)

FDA data resources