The following data is part of a premarket notification filed by Intramed Laboratories, Inc. with the FDA for Angioscope.
Device ID | K894459 |
510k Number | K894459 |
Device Name: | ANGIOSCOPE |
Classification | Angioscope |
Applicant | INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
Contact | A Sosnowski |
Correspondent | A Sosnowski INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
Product Code | LYK |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-18 |
Decision Date | 1990-03-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ANGIOSCOPE 73424457 not registered Dead/Abandoned |
TRIMEDYNE, INC. 1983-05-04 |