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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 K831975
Device Name LEADING EDGE OPHTHALMIC KNIFE
Applicant
Surgidev Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Surgidev Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4350
Classification Product Code
HNN  
Date Received06/20/1983
Decision Date 08/31/1983
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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