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510(k) K905237

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

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

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  • K860960 — RARE EARTH INTRA-OCULAR MAGNET (March 31, 1986)
  • K831702 — RARE-EARTH INTRA-OCULAR MAGNET (June 30, 1983)