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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceCELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
ALCON LABORATORIES
6201 south freeway
fort worth, TX 76134
PMA NumberP990023
Date Received05/07/1999
Decision Date02/24/2000
Product Code
LZP[ Registered Establishments with LZP ]
Docket Number 00M-0809
Notice Date 08/03/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 
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