INSTRUMED RONGEUR— 510(k) K081651
Substantially EquivalentInstrumed International, Inc.
FDA 510(k) clearance K081651 for INSTRUMED RONGEUR, Substantially Equivalent on 2008-08-08. Applicant: Instrumed International, Inc.. Device class: 2.
Clearance details
- Applicant
- Instrumed International, Inc.
- Product code
- Code HAE
- Device class
- Class 2
- Regulation
- 21 CFR 882.4840
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schaumburg, IL, US
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