The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Thora-cath.
Device ID | K941232 |
510k Number | K941232 |
Device Name: | THORA-CATH |
Classification | Catheter And Tip, Suction |
Applicant | GESCO INTL., INC. 5714 EPSILON DR. San Antonio, TX 78249 |
Contact | Clyde N Baker |
Correspondent | Clyde N Baker GESCO INTL., INC. 5714 EPSILON DR. San Antonio, TX 78249 |
Product Code | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-15 |
Decision Date | 1994-05-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H67141496091 | K941232 | 000 |
H67141414091 | K941232 | 000 |
H67141412091 | K941232 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THORA-CATH 76016454 2495841 Live/Registered |
Utah Medical Products, Inc. 2000-04-03 |
THORA-CATH 75492728 not registered Dead/Abandoned |
C. R. Bard, Inc. 1998-05-29 |