The following data is part of a premarket notification filed by Envision Medical Corp. with the FDA for Xenon Light Source.
Device ID | K951971 |
510k Number | K951971 |
Device Name: | XENON LIGHT SOURCE |
Classification | Light Source, Endoscope, Xenon Arc |
Applicant | ENVISION MEDICAL CORP. 749 WARD DR. Santa Barbara, CA 93111 |
Contact | Daniel P Mcguire |
Correspondent | Daniel P Mcguire ENVISION MEDICAL CORP. 749 WARD DR. Santa Barbara, CA 93111 |
Product Code | GCT |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-27 |
Decision Date | 1995-05-24 |