FLO ASSISTANT, MODEL 4-250-00— 510(k) K001325
Substantially EquivalentNorthgate Technologies, Inc.
FDA 510(k) clearance K001325 for FLO ASSISTANT, MODEL 4-250-00, Substantially Equivalent on 2000-08-18. Applicant: Northgate Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Northgate Technologies, Inc.
- Product code
- Code LJH
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elgin, IL, US
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