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510(k) K905237

EYE SEE INSTRUMENT by King Tool, Inc. — Product Code HPN

K905237 is an FDA 510(k) premarket notification submitted by King Tool, Inc. for the device "EYE SEE INSTRUMENT". The FDA issued a decision of Substantially Equivalent on February 14, 1991. The device falls under product code HPN (Magnet, Permanent), a Class I device regulated under 21 CFR 886.4445.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1991
Date Received
November 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Magnet, Permanent
Device Class
Class I
Regulation Number
886.4445
Review Panel
OP
Submission Type

Other clearances for product code HPN

  • K896473 — H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR (February 9, 1990)
  • K880855 — PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG (April 1, 1988)
  • K860960 — RARE EARTH INTRA-OCULAR MAGNET (March 31, 1986)
  • K831702 — RARE-EARTH INTRA-OCULAR MAGNET (June 30, 1983)

FDA data resources