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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 K952468
Device Name HI-LINE MEDICAL PHACOEMULSIFIER TIP
Applicant
Hi-Line Medical
23461 Ridge Rte.
Suite I
Laguna Hills,  CA  92653
Applicant Contact GLENN A DUNKI-JACOBS
Correspondent
Hi-Line Medical
23461 Ridge Rte.
Suite I
Laguna Hills,  CA  92653
Correspondent Contact GLENN A DUNKI-JACOBS
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/26/1995
Decision Date 08/24/1995
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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