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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 NameJ LOOP POSTERIOR CHAMBER TYPE II 0 & 10
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantCOBURN OPTICAL IND., INC.
PMA NumberP840039
Supplement NumberS006
Date Received08/01/1988
Decision Date08/21/1989
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 89M-0361
Notice Date 09/13/1989
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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