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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, phacofragmentation
510(k) Number K891161
Device Name VITRECTOMY PACK #J120
Applicant
O.R. SPECIALTIES, INC.
4749 APPLETREE LN.
TUSCALOOSA,  AL  35405
Applicant Contact JACK W HOWARD
Correspondent
O.R. SPECIALTIES, INC.
4749 APPLETREE LN.
TUSCALOOSA,  AL  35405
Correspondent Contact JACK W HOWARD
Regulation Number886.4670
Classification Product Code
HQC  
Date Received03/06/1989
Decision Date 05/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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