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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Ophthalmic
510(k) Number K871285
Device Name KNIFE, OPHTHALMIC
Applicant
Trueline Instruments, Inc.
P.O. Box 26784
Tucson,  AZ  85726
Applicant Contact M HAWORTH,JR
Correspondent
Trueline Instruments, Inc.
P.O. Box 26784
Tucson,  AZ  85726
Correspondent Contact M HAWORTH,JR
Regulation Number886.4350
Classification Product Code
HNN  
Date Received03/31/1987
Decision Date 04/27/1987
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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