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Elekta GA-269-D-102-S, Transfer from Georgia - Package 2 of 2.

Accession Number: ML14091A325

Date Released: Wednesday, April 9, 2014

Package Contents

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• ML14091A335 - Elekta Fax dated 07/30/99, From P. Summer to E. Jameson re: 510(K) - GA-269-D-102-S. (20 page(s), 7/30/1999)
• ML14091A336 - Letter dated 09/20/1999, from Elekta instruments, Inc., Providing Copies of Final Documentation Itemized for Inclusion in the Company's Request of Modifications to the "Registry of Radioactive Sealed Sources and Devices Safety Evaluation of Device"..... (1 page(s), 9/20/1999)
• ML14091A337 - Letter dated April 1, 1998, from Dept of Health & Human Services re: Notification of Intent to Market the K973441, Leksell GammPlan (Radionuclide Radiation Therapy Planning System). (1 page(s), 4/1/1998)
• ML14091A338 - Transmittal of amended "Registry of Radioactive Sealed Sources and Devices Safety Evaluation of Device" Numbers GA-269-D-101-S, Leksell Gamma System Model 23016, and GA-D-102-S, Leksell Gamma System Model 23004 or 24001. (1 page(s), 3/27/2001)
• ML14091A339 - Transmittal of Request Amendment to SS&D Certificate GA-269-S-103-S, adding to the Model 1000029 and Amended Cover Page for GA-269-D-102-S, Reflecting the Model 100029 as a Source Option for Type B, B-2 and Type C Units. (1 page(s), 3/26/2007)
• ML14091A340 - Transmittal of Listed Registry of Radioactive Sealed Sources and Devices Safety Evaluation of Device Number for Distribution. (1 page(s), 3/26/2007)