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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, vitreous aspiration and cutting, ac-powered
510(k) Number K121675
Device Name VERSAVIT
Original Applicant
3845 corporate centre drive
o'fallon,  MO  63368
Original Contact dan regan
Regulation Number886.4150
Classification Product Code
Date Received06/06/2012
Decision Date 06/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No