510(k) K870898
K870898 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "ULTRA-LUX LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on March 18, 1987. The device falls under product code FSW (Light, Surgical, Endoscopic), a Class II device regulated under 21 CFR 878.4580. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 1987
- Date Received
- March 5, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Endoscopic
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type