510(k) K896364
K896364 is an FDA 510(k) premarket notification submitted by Nevin Laboratories, Inc. for the device "DECIDENT". The FDA issued a decision of Substantially Equivalent on July 19, 1990. The device falls under product code EKY (Handpiece, Water-Powered), a Class I device regulated under 21 CFR 872.4200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1990
- Date Received
- November 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Water-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type