510(k) K041754
K041754 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER MAESTRO SYSTEM". The FDA issued a decision of Substantially Equivalent on September 7, 2004. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Stryker Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 2004
- Date Received
- June 29, 2004
- 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