510(k) K931675
K931675 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS". The FDA issued a decision of Substantially Equivalent on February 22, 1994. The device falls under product code FTD (Lamp, Surgical), 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
- February 22, 1994
- Date Received
- April 6, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type