The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Umbili-cath-s.
Device ID | K940953 |
510k Number | K940953 |
Device Name: | UMBILI-CATH-S |
Classification | Catheter, Umbilical Artery |
Applicant | GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
Contact | Clyde N Baker |
Correspondent | Clyde N Baker GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
Product Code | FOS |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-01 |
Decision Date | 1994-08-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H67141865051 | K940953 | 000 |
H67141850051 | K940953 | 000 |
H67141835051 | K940953 | 000 |
H67141828051 | K940953 | 000 |
H67141780051 | K940953 | 000 |
H67141750051 | K940953 | 000 |
H67140735051 | K940953 | 000 |