510(k) K893828

ML-800 AUTOELECTRONIC LIGHT SOURCE by M.P. Video, Inc. — Product Code FST

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