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20-08361-01 589945 Department of Health and Human Services.

Accession Number: ML16021A400

Date Released: Friday, March 25, 2016

Package Contents

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• ML16021A409 - Department of Health and Human Services, Amendment Request Letter dtd December 30, 2015. (3 page(s), 12/30/2015)
• ML16039A286 - Department of Health and Human Services, FDA, Telephone Conversation Record dated 12/28/2015, Received in LAT on 01/28/2016, Subject: New Fee Rule, and Locations of Use. (2 page(s), 12/28/2015)
• ML16040A038 - Department of Health and Human Services, FDA; Telephone Conversation Record dated 02/01/16 Subject: RAI, Documents Needed. (2 page(s), 2/1/2016)
• ML16055A194 - Department of Health and Human Services, Deficiency Response Ltr. Dated February 5, 2016. (9 page(s), 2/5/2016)
• ML16063A412 - Department of Health & Human Services, Telephone Conversation Record dtd 2/24/2016, RE: Additional Deficiency Request - Denver Facility Release, Control No. 589945. (1 page(s), 2/24/2016)
• ML16064A181 - Department of Health and Human Services, Additional Deficiency Response Letter Rec'd in LAT 2-22-16, Control No. 589945. (22 page(s), 2/22/2016)
• ML16077A157 - Department of Health and Human Services, Additional Deficiency Response Letter Rec'd in LAT 3/7/16, Control No. 589945. (5 page(s), 3/3/2016)