CORNEAL SCLERAL LANCE

Knife, Ophthalmic

SHARPOINT, INC.

The following data is part of a premarket notification filed by Sharpoint, Inc. with the FDA for Corneal Scleral Lance.

Pre-market Notification Details

Device IDK840855
510k NumberK840855
Device Name:CORNEAL SCLERAL LANCE
ClassificationKnife, Ophthalmic
Applicant SHARPOINT, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeHNN  
CFR Regulation Number886.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-24
Decision Date1984-05-09

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