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 |