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2006N-0335: Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
NPR1   09/22/2006 FDA FDA 09/25/2006 55748-55755 12/11/2006 txt  
Signature: Jeffrey Shuren
NFR1   09/22/2006 FDA FDA 09/25/2006 55729-55737 12/11/2006 txt Effective 2/7/2007
Signature: Jeffrey Shuren
EC1 11/29/2006 11/28/2006 Health Professional Mr. michael nichols       htm  
EC2 12/08/2006 12/07/2006 Device Industry Alcon Research, Ltd.       pdf  
Signature: Heidel, Garry
NWL1   01/09/2007 FDA FDA 01/12/2007 1460-1460   txt  
Signature: SHUREN, JEFFREY

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Page last updated: January 17, 2007