510(k) K945659
K945659 is an FDA 510(k) premarket notification submitted by Xomed-Treace, Inc. for the device "BLACKSTAR(TM) STAR SYSTEM". The FDA issued a decision of Substantially Equivalent on January 9, 1995. 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. Xomed-Treace, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1995
- Date Received
- November 17, 1994
- 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