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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 K984540
Device Name KERAVISION VACUUM RING SYSTEM
Applicant
KERAVISION, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact HOWARD H HOLSTEIN
Correspondent
KERAVISION, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact HOWARD H HOLSTEIN
Regulation Number886.4370
Classification Product Code
HNO  
Date Received12/21/1998
Decision Date 04/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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