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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
Bausch & Lomb, Inc.
1400 north goodman st.
rochester, NY 14609-3547
PMA NumberP870073
Supplement NumberS007
Date Received01/10/1992
Decision Date04/28/1993
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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