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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 K853883
Device Name TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR
Applicant
Medical Corp. of America
28481 La Falda
Laguna Niguel,  CA  92677
Applicant Contact THOMAS V KEELEY
Correspondent
Medical Corp. of America
28481 La Falda
Laguna Niguel,  CA  92677
Correspondent Contact THOMAS V KEELEY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received09/19/1985
Decision Date 10/08/1985
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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