510(k) K893828
K893828 is an FDA 510(k) premarket notification submitted by M.P. Video, Inc. for the device "ML-800 AUTOELECTRONIC LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on July 24, 1989. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. M.P. Video, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 1989
- Date Received
- May 24, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Fiberoptic
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type