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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.
DeviceMODELS 019B, 019C, 019E, 019F, 019J, & 019K
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
1700 e. st. andrew place
p.o. box 25162
santa ana, CA 92705-4933
PMA NumberP810055
Supplement NumberS017
Date Received03/28/1986
Decision Date10/06/1987
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 87M-0347
Notice Date 11/16/1987
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason other report
Expedited Review Granted? No
Combination Product No