Omni Instrument Tray— 510(k) K182052
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K182052 for Omni Instrument Tray, Substantially Equivalent on 2019-02-26. Applicant: Hologic, Inc.. Device class: 2.
Clearance details
- Applicant
- Hologic, 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
- Malborough, MA, US
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