The following data is part of a premarket notification filed by Nelmed Corp. with the FDA for Urine Collector & Accessories.
| Device ID | K945204 |
| 510k Number | K945204 |
| Device Name: | URINE COLLECTOR & ACCESSORIES |
| Classification | Bag, Urine Collection, Leg, For External Use, Sterile |
| Applicant | NELMED CORP. 35 HAWTHORNE ST. North Attleboro, MA 02760 |
| Contact | Erik Nelson |
| Correspondent | Erik Nelson NELMED CORP. 35 HAWTHORNE ST. North Attleboro, MA 02760 |
| Product Code | FAQ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-25 |
| Decision Date | 1994-11-02 |