The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Critiflo & Critiflo Dome.
| Device ID | K791844 |
| 510k Number | K791844 |
| Device Name: | CRITIFLO & CRITIFLO DOME |
| Classification | Catheter, Continuous Flush |
| 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 | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-19 |
| Decision Date | 1979-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450323162 | K791844 | 000 |