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510(k) K812011

BLADE GAUGE by Koi, Inc. — Product Code HOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1981
Date Received
July 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Caliper, Ophthalmic
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)
  • K812097 — KOI LACREMAL HOOK & DILATOR (August 18, 1981)
  • K812010 — KOI LACRIMAL INTUBATION SYSTEM (July 28, 1981)

Other clearances for product code HOE

  • K881094 — KOI(TM) BLADE GAUGE, MODEL KOI-132 (April 1, 1988)
  • K813315 — CALIPER-OPTHALMIC (March 1, 1982)
  • K820050 — KREMER BLADE GAUGE (February 24, 1982)
  • K801937 — BLEPHAROMETER (September 16, 1980)
  • K792383 — KELMAN DIPSTICK (December 11, 1979)
  • K781715 — RULER, WECK SCOTT (December 4, 1978)