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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.
 
Trade NameCELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
Classification Nameaid, surgical, viscoelastic
Generic Nameophthalmic viscosurgical device
Regulation Number886.4275
ApplicantALCON LABORATORIES
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 
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