510(k) K902653
K902653 is an FDA 510(k) premarket notification submitted by Intl. Equipment and Supply Corp. for the device "PDS-2000". The FDA issued a decision of Substantially Equivalent on September 13, 1990. The device falls under product code EIK (Carver, Wax, Dental), a Class I device regulated under 21 CFR 872.4565.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 1990
- Date Received
- June 15, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carver, Wax, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type