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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Irrigation, Ocular Surgery
510(k) Number K861203
Device Name MULTI-SPIKE
Applicant
Surgeon Surgical Instrumentation, Inc.
1061 N. Shepard St.
Suite C
Anaheim,  CA  92806
Applicant Contact ARMAND MAASKAMP
Correspondent
Surgeon Surgical Instrumentation, Inc.
1061 N. Shepard St.
Suite C
Anaheim,  CA  92806
Correspondent Contact ARMAND MAASKAMP
Regulation Number886.4360
Classification Product Code
KYG  
Date Received04/01/1986
Decision Date 04/28/1986
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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