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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Ophthalmic
510(k) Number K872200
Device Name HAMACHER BULLET POINT OPHTHALMIC NEEDLE
Applicant
R. J. Doyle, Inc.
West 105 Eighth Ave.,
Suite 660
Spokane,  WA  99204
Applicant Contact EDWARD N HAMACHER
Correspondent
R. J. Doyle, Inc.
West 105 Eighth Ave.,
Suite 660
Spokane,  WA  99204
Correspondent Contact EDWARD N HAMACHER
Regulation Number886.4350
Classification Product Code
HMX  
Date Received06/08/1987
Decision Date 06/25/1987
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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