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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade Name1CDELS B-13F (P-10) & B-1H (P-11)
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantCOOPERVISION, INC.
PMA NumberP810032
Supplement NumberS028
Date Received12/22/1988
Decision Date11/22/1989
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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