510(k) K073633
K073633 is an FDA 510(k) premarket notification submitted by Stryker Ireland Ltd., Instruments Division for the device "STRYKER ESSX MICRODEBRIDER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 26, 2008. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. Stryker Ireland Ltd., Instruments Division has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 2008
- Date Received
- December 26, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device Class
- Class II
- Regulation Number
- 874.4250
- Review Panel
- EN
- Submission Type