510(k) K150660
- Device
- Alcyone MEMS Cannula (AMC) System
- Applicant
- ALCYONE LIFESCIENCES, INC.
- 510(k) number
- K150660
- Product code
- HCD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-16
- Date received
- 2015-03-13
- Regulation
- 882.4060
- Classification name
- Cannula, Ventricular
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- ELSA CHI ABRUZZO
- Address
- 130 John St., Boot Canal Mill Bldg., C-2 Lowell MA US 01852 01852
FDA Registration Numbers#
- 3014334038
- 1412854
- 3028006458
- 1421879
- 2648988
- 1836161
- 8040278
- 3008902714
- 1923569
- 9611827
- 2916714
- 3008770252
- 3007773213
- 2029275
- 3012226300
- 1421101
- 3012995405
- 8030607
- 3003418325
- 3005528784
- 9610612
Source Documents#
Other 510(k) Records For Product Code HCD #
Legacy Summary#
summary
FDA Review#
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