510(k) K153311
- Device
- Flexitouch System
- Applicant
- TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL)
- 510(k) number
- K153311
- Product code
- PPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-09-14
- Date received
- 2015-11-17
- Regulation
- 870.5800
- Classification name
- Sleeve, Head And Neck, Compressible
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Thomas A Dold
- Address
- 1331 Tyler St. NE, Suite 200 Minneapolis MN US 55413 55413
FDA Registration Numbers#
- 3004183730
- 3014344059
Source Documents#
Legacy Summary#
summary
FDA Review#
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