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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Irrigation, Ocular Surgery
510(k) Number K003036
Device Name TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
Applicant
Retinalabs.Com
1776 Peachtree St.
200 N.
Atlanta,  GA  30309
Applicant Contact FRANK TIGHE
Correspondent
Retinalabs.Com
1776 Peachtree St.
200 N.
Atlanta,  GA  30309
Correspondent Contact FRANK TIGHE
Regulation Number886.4360
Classification Product Code
KYG  
Date Received09/29/2000
Decision Date 12/22/2000
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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