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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Ophthalmic (Flieringa)
510(k) Number K863775
Device Name RK VACUUM FIXATION RING SYSTEM
Applicant
Ameritek, Inc.
7030 35th Ave., NE
Seattle,  WA  98115
Applicant Contact ROBERT GALAN
Correspondent
Ameritek, Inc.
7030 35th Ave., NE
Seattle,  WA  98115
Correspondent Contact ROBERT GALAN
Regulation Number886.4350
Classification Product Code
HNH  
Date Received09/26/1986
Decision Date 10/20/1986
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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