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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Sphere
510(k) Number K895908
Device Name MULES SPHERE GLASS (SEVERAL SIZES)
Applicant
Ginsberg Scientific, Inc.
Rte. 2, Box 290
Macks Creek,  MO  65786
Applicant Contact EDITH L WILSON
Correspondent
Ginsberg Scientific, Inc.
Rte. 2, Box 290
Macks Creek,  MO  65786
Correspondent Contact EDITH L WILSON
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received10/10/1989
Decision Date 01/08/1990
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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