The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Standard Foley System Pak.
| Device ID | K951443 |
| 510k Number | K951443 |
| Device Name: | STANDARD FOLEY SYSTEM PAK |
| Classification | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Applicant | TRINITY LABORATORIES, INC. 201 KELLY DR. Salisbury, MD 21801 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KELLY DR. Salisbury, MD 21801 |
| Product Code | FCN |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-29 |
| Decision Date | 1995-06-15 |