510(k) DEN210037
- Device
- SoClean 3+ Bacterial Reduction Device
- Applicant
- Soclean, Inc.
- 510(k) number
- DEN210037
- Product code
- QXQ
- Decision
- Unknown (DENG)
- Decision date
- 2024-08-12
- Date received
- 2021-09-15
- Regulation
- 880.6993
- Classification name
- Respiratory Accessory Microbial Reduction Device.
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- George Peters
- Address
- 12 Vose Farm Rd. Peterborough NH US 03458 03458
FDA Registration Numbers#
- 3003927385
- 3009534409
Source Documents#
510(k) summary PDF not indicated by FDA