The following data is part of a premarket notification filed by Telos Medical Corp. with the FDA for Lab-site.
Device ID | K905017 |
510k Number | K905017 |
Device Name: | LAB-SITE |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | TELOS MEDICAL CORP. 2044 WEST 11TH ST. KEENE, CA 91786 |
Contact | TIMOTHY J TALCOTT |
Correspondent | TIMOTHY J TALCOTT TELOS MEDICAL CORP. 2044 WEST 11TH ST. KEENE, CA 91786 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-07 |
Decision Date | 1991-01-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LAB-SITE 73635420 1476720 Live/Registered |
MIGADA LTD. 1986-12-15 |