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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratome, Ac-Powered
510(k) Number K870807
Device Name BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE
Applicant
Allergan, Inc.
Post Office Box 25155
Santa Ana,  CA  92799
Applicant Contact PAUL S KRAMSKY
Correspondent
Allergan, Inc.
Post Office Box 25155
Santa Ana,  CA  92799
Correspondent Contact PAUL S KRAMSKY
Regulation Number886.4370
Classification Product Code
HNO  
Date Received02/27/1987
Decision Date 05/29/1987
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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