510(k) K904587
K904587 is an FDA 510(k) premarket notification submitted by L. Keroack Co. for the device "DENSICOMP 250". The FDA issued a decision of Substantially Equivalent on Jan 24, 1991. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), a Class II device regulated under 21 CFR 892.1610.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 24, 1991
- Date Received
- Oct 9, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Beam Limiting, X-Ray, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1610
- Review Panel
- RA
- Submission Type
- 510(k) Exempt