510(k) K061725
K061725 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "STRYKER ARIA PNEUMATIC SYSTEM". The FDA issued a decision of Substantially Equivalent on October 26, 2006. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Stryker Instruments has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2006
- Date Received
- June 19, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Drill, Pneumatic
- Device Class
- Class II
- Regulation Number
- 882.4370
- Review Panel
- NE
- Submission Type