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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
Applicant
SYNERGETICS, INC
3845 CORPORATE CENTRE DRIVE
O'FALLON,  MO  63368
Applicant Contact DAN REGAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number886.4150
Classification Product Code
HQE  
Date Received06/06/2012
Decision Date 06/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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