The following data is part of a premarket notification filed by M.p. Video, Inc. with the FDA for Medicam Xenon Light Source.
Device ID | K943342 |
510k Number | K943342 |
Device Name: | MEDICAM XENON LIGHT SOURCE |
Classification | Light, Surgical, Endoscopic |
Applicant | M.P. VIDEO, INC. 4 MARC RD. Medway, MA 02053 |
Contact | Winifred Shannon |
Correspondent | Winifred Shannon M.P. VIDEO, INC. 4 MARC RD. Medway, MA 02053 |
Product Code | FSW |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-12 |
Decision Date | 1994-10-17 |