510(k) K003090
K003090 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 18, 2000. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Midmark Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2000
- Date Received
- October 3, 2000
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type