510(k) K133724
- Device
- MINNCARE HD
- Applicant
- MEDIVATORS, INC.
- 510(k) number
- K133724
- Product code
- NIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-08-27
- Date received
- 2013-12-06
- Regulation
- 876.5665
- Classification name
- Disinfectant, Subsystem, Water Purification
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KINNARI SHAH
- Address
- 14605 28th Ave. N. Minneapolis MN US 55447 55447
FDA Registration Numbers#
- 3014150341
- 1937310
- 1527821
- 2150060
Source Documents#
Legacy Summary#
summary
FDA Review#
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