The following data is part of a premarket notification filed by Mediquest, Inc. with the FDA for Female External Urinary Collection Pouch.
| Device ID | K971499 |
| 510k Number | K971499 |
| Device Name: | FEMALE EXTERNAL URINARY COLLECTION POUCH |
| Classification | Device, Paste-on For Incontinence, Sterile |
| Applicant | MEDIQUEST, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland MEDIQUEST, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | EXI |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-25 |
| Decision Date | 1997-08-28 |