The following data is part of a premarket notification filed by M.p. Video, Inc. with the FDA for Ml-800 Autoelectronic Light Source.
Device ID | K893828 |
510k Number | K893828 |
Device Name: | ML-800 AUTOELECTRONIC LIGHT SOURCE |
Classification | Light, Surgical, Fiberoptic |
Applicant | M.P. VIDEO, INC. 65 SOUTH ST. Hopkinton, MA 01748 |
Contact | Patricia Carpenter |
Correspondent | Patricia Carpenter M.P. VIDEO, INC. 65 SOUTH ST. Hopkinton, MA 01748 |
Product Code | FST |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-24 |
Decision Date | 1989-07-24 |