510(k) K834606
K834606 is an FDA 510(k) premarket notification submitted by Knochen Dental Laboratory for the device "X-RAY COLLIMATOR X-CJD". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code EHB (Collimator, X-Ray), a Class I device regulated under 21 CFR 872.1840. Knochen Dental Laboratory has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1984
- Date Received
- December 28, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collimator, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1840
- Review Panel
- RA
- Submission Type