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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameINTACS PRESCRIPTION INSERTS FOR KERATOCONUS
Classification Nameimplant, corneal, refractive
Generic Nameimplant, corneal, refractive
Applicant
ADDITION TECHNOLOGY
820 oak creek drive
lombard, IL 60148
HDE NumberH040002
Date Received03/03/2004
Decision Date07/26/2004
Product Code
LQE[ Registered Establishments with LQE ]
Docket Number 06M-0233
Notice Date 06/09/2006
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S003 S004 
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