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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, microsurgical
510(k) Number K890216
Device Name MICROSURGICAL KERATOME
Applicant
KINETIC MEDICAL PRODUCTS
4934 PEACH ST.
ERIE,  PA  16509
Applicant Contact JAMES I LAUGHNER
Correspondent
KINETIC MEDICAL PRODUCTS
4934 PEACH ST.
ERIE,  PA  16509
Correspondent Contact JAMES I LAUGHNER
Regulation Number882.4525
Classification Product Code
GZX  
Date Received01/18/1989
Decision Date 02/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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