510(k) K202073
- Device
- NeedleSmart Professional (NS Pro)
- Applicant
- NeedleSmart Limited
- 510(k) number
- K202073
- Product code
- MTV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-25
- Date received
- 2020-07-27
- Regulation
- 880.6210
- Classification name
- Sharps Needle Destruction Device
- 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
- Tom Baker
- Address
- Suite 2b, Stanley Grange Business Park, Ormskirk Rd. Knowsley, Prescot GB L34 5NB L34 5NB
Source Documents#
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases