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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 K843319
Device Name CILCO I/A SURGICAL PACK
Applicant
CILCO, INC.
1616 13TH. AVE.
SUITE 200
HUNTINGTON,  WV  25701
Applicant Contact RICH MCCARLEY
Correspondent
CILCO, INC.
1616 13TH. AVE.
SUITE 200
HUNTINGTON,  WV  25701
Correspondent Contact RICH MCCARLEY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received08/24/1984
Decision Date 02/14/1985
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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