D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)— 510(k) K081821
Substantially EquivalentGlobal Pathogen Solutions, Inc.
FDA 510(k) clearance K081821 for D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP), Substantially Equivalent on 2008-09-02. Applicant: Global Pathogen Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Global Pathogen Solutions, 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
- Camas, WA, US
Recent devices under product code MMK
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