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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hook, Ophthalmic
510(k) Number K864292
Device Name DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY
Applicant
Eye-Ko, Inc.
P.O. Box 1632
West Chester,  PA  19380
Applicant Contact GREGORY L BEINECKE
Correspondent
Eye-Ko, Inc.
P.O. Box 1632
West Chester,  PA  19380
Correspondent Contact GREGORY L BEINECKE
Regulation Number886.4350
Classification Product Code
HNQ  
Date Received10/31/1986
Decision Date 12/29/1986
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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