510(k) K063151
- Device
- HUMAPEN LUXURA HD
- Applicant
- ELI LILLY AND CO.
- 510(k) number
- K063151
- Product code
- NSC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-01-09
- Date received
- 2006-10-16
- Regulation
- 880.5860
- Classification name
- Injector, Pen
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEEANN CHAMBERS
- Address
- Lilly Corporate Center Indianapolis IN US 46285 46285
FDA Registration Numbers#
- 3005627859
- 3007135538
- 1832816
- 3002806818
- 3012775596
- 2182861
- 9681538
- 3002522469
- 3038356900
- 3004627792
- 3004598644
- 3014585508
- 3010515547
- 1000150646
Source Documents#
Legacy Summary#
summary
FDA Review#
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