ULTRASHARP CONCENTRIC NEEDLES— 510(k) K080914
Substantially EquivalentRochester Electro Medical, Inc.
FDA 510(k) clearance K080914 for ULTRASHARP CONCENTRIC NEEDLES, Substantially Equivalent on 2008-07-15. Applicant: Rochester Electro Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Rochester Electro Medical, Inc.
- Product code
- Code IKT
- Device class
- Class 2
- Regulation
- 21 CFR 890.1385
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Lutz, FL, US
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