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510(k) K843247

KOI PACHYMETER by Koi, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1986
Date Received
August 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Koi, Inc.

  • 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)
  • K812011 — BLADE GAUGE (July 28, 1981)

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