ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER— 510(k) K081449
Substantially EquivalentUltimed, Inc.
FDA 510(k) clearance K081449 for ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER, Substantially Equivalent on 2008-06-03. Applicant: Ultimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Ultimed, Inc.
- Product code
- Code MMK
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
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