The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Catheter Connection W/integral Injectate.
Device ID | K830523 |
510k Number | K830523 |
Device Name: | CATHETER CONNECTION W/INTEGRAL INJECTATE |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | GOULD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | None None |
Correspondent | None None GOULD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-17 |
Decision Date | 1983-03-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884450330729 | K830523 | 000 |
10884450330743 | K830523 | 000 |
10884450361020 | K830523 | 000 |
10884450330736 | K830523 | 000 |