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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lacrimal Stents And Intubation Sets
510(k) Number K935233
Device Name IOLAB LACRIMAL DUCT CATHETER
Applicant
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact SUSAN H CABALLA
Correspondent
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact SUSAN H CABALLA
Classification Product Code
OKS  
Date Received11/01/1993
Decision Date 09/15/1994
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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