iTotal Family Reusable Instrument Tray— 510(k) K170226
Substantially EquivalentConformis, Inc.
FDA 510(k) clearance K170226 for iTotal Family Reusable Instrument Tray, Substantially Equivalent on 2017-10-25. Applicant: Conformis, Inc.. Device class: 2.
Clearance details
- Applicant
- Conformis, Inc.
- Product code
- Code KCT
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.