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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 K890825
Device Name JUMPER PACK #203
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 Received02/17/1989
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
Predetermined Change
Control Plan Authorized		 No
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