510(k) DEN150029
- Device
- Permaseal
- Applicant
- Micro Interventional Devices,Inc.
- 510(k) number
- DEN150029
- Product code
- PNQ
- Decision
- Unknown (DENG)
- Decision date
- 2016-07-27
- Date received
- 2015-06-22
- Regulation
- 870.4510
- Classification name
- Apical Closure Device
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- LINDA MORGAN
- Address
- 5 Caufield Pl., Suite 102 Newtown PA US 18940 18940
Source Documents#
510(k) summary PDF not indicated by FDA