510(k) K834606

X-RAY COLLIMATOR X-CJD by Knochen Dental Laboratory — Product Code EHB

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