ALEXIS LAPAROSCOPIC SYSTEM— 510(k) K093296
Substantially EquivalentApplied Medical Resources Corp.
FDA 510(k) clearance K093296 for ALEXIS LAPAROSCOPIC SYSTEM, Substantially Equivalent on 2009-11-05. Applicant: Applied Medical Resources Corp.. Device class: 2.
Clearance details
- Applicant
- Applied Medical Resources Corp.
- Product code
- Code KGW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Santa, CA, US
Recent devices under product code KGW
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