510(k) K802463
K802463 is an FDA 510(k) premarket notification submitted by Spire Medical, Inc. for the device "MICRO-SURGICAL POWER INSTRUMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 1980. 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. Spire Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1980
- Date Received
- October 9, 1980
- 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