VERSAVIT


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
Regulation Number 886.4150
Classification Product Code
HQE  
Date Received 06/06/2012
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