The following data is part of a premarket notification filed by Trinity Partners, Llc. with the FDA for Venoscope.
Device ID | K941035 |
510k Number | K941035 |
Device Name: | VENOSCOPE |
Classification | Transilluminator, Battery-powered |
Applicant | TRINITY PARTNERS, LLC. P.O. BOX 52703 Lafayette, LA 70505 -2703 |
Contact | Frank C Creaghan |
Correspondent | Frank C Creaghan TRINITY PARTNERS, LLC. P.O. BOX 52703 Lafayette, LA 70505 -2703 |
Product Code | HJN |
CFR Regulation Number | 886.1945 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-07 |
Decision Date | 1994-05-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B853VT030 | K941035 | 000 |
B853NT010 | K941035 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VENOSCOPE 74473756 1934681 Live/Registered |
VENOSCOPE, LLC 1993-12-22 |
VENOSCOPE 74203513 not registered Dead/Abandoned |
Applied Biotech Products, Inc. 1991-09-16 |