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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K930628
Device Name KLAAS IOL LENSFOLDER
Applicant
Bova Intl.
2217 Sixth Ave.
Fort Worth,  TX  76116
Applicant Contact BODO OEHLER
Correspondent
Bova Intl.
2217 Sixth Ave.
Fort Worth,  TX  76116
Correspondent Contact BODO OEHLER
Regulation Number886.4300
Classification Product Code
KYB  
Date Received02/08/1993
Decision Date 02/07/1995
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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