NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT— 510(k) K122784
Substantially EquivalentBioness, Inc.
FDA 510(k) clearance K122784 for NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT, Substantially Equivalent on 2012-12-27. Applicant: Bioness, Inc.. Device class: 2.
Clearance details
- Applicant
- Bioness, Inc.
- Product code
- Code GZI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5810
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valencia, CA, US
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