510(k) K945438
K945438 is an FDA 510(k) premarket notification submitted by Micromed Development Corp. for the device "EDI-BUR MICRODRILL SYSTEMS". The FDA issued a decision of Substantially Equivalent on November 22, 1994. 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. Micromed Development Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1994
- Date Received
- October 20, 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