510(k) K882810
K882810 is an FDA 510(k) premarket notification submitted by Wy'East Medical Corp. for the device "EASY-OP, PORTABLE DENTAL CART". The FDA issued a decision of Substantially Equivalent on August 12, 1988. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Wy'East Medical Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1988
- Date Received
- July 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type