FOLEY-TEMP
Catheter, Urological
MALLINCKRODT CRITICAL CARE
The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Foley-temp.
Pre-market Notification Details
| Device ID | K831567 |
| 510k Number | K831567 |
| Device Name: | FOLEY-TEMP |
| Classification | Catheter, Urological |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-16 |
| Decision Date | 1983-08-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521078062 | K831567 | 000 |
| 30884521826414 | K831567 | 000 |
| 20884521826424 | K831567 | 000 |
| 30884521826438 | K831567 | 000 |
| 20884521826448 | K831567 | 000 |
| 20884521826455 | K831567 | 000 |
| 10884521077584 | K831567 | 000 |
| 20884521077598 | K831567 | 000 |
| 10884521078017 | K831567 | 000 |
| 20884521078021 | K831567 | 000 |
| 10884521078031 | K831567 | 000 |
| 20884521826400 | K831567 | 000 |
Trademark Results [FOLEY-TEMP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FOLEY-TEMP 73457451 not registered Dead/Abandoned |
Mallinckrodt, Inc. 1983-12-16 |
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