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510(k) K812097

KOI LACREMAL HOOK & DILATOR by Koi, Inc. — Product Code HNW

K812097 is an FDA 510(k) premarket notification submitted by Koi, Inc. for the device "KOI LACREMAL HOOK & DILATOR". The FDA issued a decision of Substantially Equivalent on August 18, 1981. The device falls under product code HNW (Dilator, Lachrymal), a Class I device regulated under 21 CFR 886.4350. Koi, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1981
Date Received
July 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Koi, Inc.

  • K843247 — KOI PACHYMETER (April 30, 1986)
  • K830366 — DIAMOND KNIFE (March 9, 1983)
  • K812764 — KOI BLUE FIELD ENTOPTOSCOPE (December 2, 1981)
  • K812450 — KOI DIAMOND KNIFE (September 21, 1981)
  • K812010 — KOI LACRIMAL INTUBATION SYSTEM (July 28, 1981)
  • K812011 — BLADE GAUGE (July 28, 1981)

Other clearances for product code HNW

  • K862070 — INTER-SHARP (June 17, 1986)
  • K841002 — LACHRYMAL PROBES-VARIOUS (May 9, 1984)

FDA data resources