510(k) K843901
K843901 is an FDA 510(k) premarket notification submitted by Shofu Dental Corp. for the device "ISOSTATIC CONDENSER". The FDA issued a decision of Substantially Equivalent on December 3, 1984. The device falls under product code EKG (Condenser, Amalgam And Foil, Operative), a Class I device regulated under 21 CFR 872.4565. Shofu Dental Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1984
- Date Received
- October 3, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condenser, Amalgam And Foil, Operative
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type