510(k) K821790
K821790 is an FDA 510(k) premarket notification submitted by Pacific Dental Corp. for the device "BEACH EXCAVATOR'S NO. 1 & NO. 2". The FDA issued a decision of Substantially Equivalent on July 6, 1982. The device falls under product code EKD (Instrument, Cutting, Operative), a Class I device regulated under 21 CFR 872.4565. Pacific Dental Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 1982
- Date Received
- June 17, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Cutting, Operative
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type