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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name keratome, battery-powered
510(k) Number K781412
Device Name OSCILLATING KNIFE AND ACCESSORIES
Applicant
Codman & Shurtleff, Inc.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
Codman & Shurtleff, Inc.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.4370
Classification Product Code
HMY  
Date Received08/15/1978
Decision Date 10/11/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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