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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Ophthalmic
510(k) Number K812450
Device Name KOI DIAMOND KNIFE
Applicant
Koi, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Koi, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.4350
Classification Product Code
HNN  
Date Received08/28/1981
Decision Date 09/21/1981
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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