510(k) K081651
K081651 is an FDA 510(k) premarket notification submitted by Instrumed International, Inc. for the device "INSTRUMED RONGEUR". The FDA issued a decision of Substantially Equivalent on August 8, 2008. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Instrumed International, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2008
- Date Received
- June 12, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Manual
- Device Class
- Class II
- Regulation Number
- 882.4840
- Review Panel
- NE
- Submission Type