510(k) K003916
- Device
- DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
- Applicant
- Scandia Manufacturing , Ltd.
- 510(k) number
- K003916
- Product code
- IMB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-04-15
- Date received
- 2000-12-19
- Regulation
- 890.5250
- Classification name
- Cabinet, Moist Steam
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD E BERGLUND
- Address
- 9220 James Ave. S. Bloomington MN US 55431 55431
FDA Registration Numbers#
- 3013689783
- 3021656665
- 3010427504
- 3013395414
- 3013601329
- 3015063984
- 3013627744
- 3030650016
- 3004126239
Source Documents#
510(k) summary PDF not indicated by FDA