510(k) K951004
K951004 is an FDA 510(k) premarket notification submitted by Kenex , Ltd. for the device "2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)". The FDA issued a decision of Substantially Equivalent on April 10, 1995. The device falls under product code KPY (Shield, Protective, Personnel), a Class I device regulated under 21 CFR 892.6500. Kenex , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1995
- Date Received
- February 15, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shield, Protective, Personnel
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type