MINIGUARD— 510(k) K954215
Substantially EquivalentAdvanced Surgical Intervention, Inc.
FDA 510(k) clearance K954215 for MINIGUARD, Substantially Equivalent on 1996-05-08. Applicant: Advanced Surgical Intervention, Inc.. Device class: 1.
Clearance details
- Applicant
- Advanced Surgical Intervention, Inc.
- Product code
- Code MNG
- Device class
- Class 1
- Regulation
- 21 CFR 876.5160
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dana Point, CA, US
Recent devices under product code MNG
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