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510(k) K812097

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

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)