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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Magnet, Permanent
510(k) Number K905237
Device Name EYE SEE INSTRUMENT
Applicant
King Tool, Inc.
5350 Love Ln.
Bozeman,  MT  59718
Applicant Contact CLARENCE A EMERSON
Correspondent
King Tool, Inc.
5350 Love Ln.
Bozeman,  MT  59718
Correspondent Contact CLARENCE A EMERSON
Regulation Number886.4445
Classification Product Code
HPN  
Date Received11/16/1990
Decision Date 02/14/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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