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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
Recalls CDRH Recalls
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