INTRODUCER SHEATH— 510(k) K001328
Substantially EquivalentNovasys Medical, Inc.
FDA 510(k) clearance K001328 for INTRODUCER SHEATH, Substantially Equivalent on 2000-07-17. Applicant: Novasys Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Novasys Medical, Inc.
- Product code
- Code FEC
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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