510(k) K970594
K970594 is an FDA 510(k) premarket notification submitted by Teledyne Water Pik for the device "KALGINATE IMPRESSION MATERIAL". The FDA issued a decision of Substantially Equivalent on March 31, 1997. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Teledyne Water Pik has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1997
- Date Received
- February 18, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type