510(k) K913405
K913405 is an FDA 510(k) premarket notification submitted by Gresco Products, Inc. for the device "KAR-D-TEK". The FDA issued a decision of Substantially Equivalent on October 28, 1991. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740. Gresco Products, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1991
- Date Received
- July 30, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Caries Detection
- Device Class
- Class II
- Regulation Number
- 872.1740
- Review Panel
- DE
- Submission Type