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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 K822112
Device Name OPHTHALMIC KNIFE
Applicant
SHARPOINT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SHARPOINT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.4350
Classification Product Code
HNN  
Date Received07/19/1982
Decision Date 08/10/1982
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
Recalls CDRH Recalls
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