The following data is part of a premarket notification filed by Uro Pharmaceuticals, Inc. with the FDA for Ob-ph - Ph Test Paper.
| Device ID | K850858 |
| 510k Number | K850858 |
| Device Name: | OB-PH - PH TEST PAPER |
| Classification | Paper, Obstetric Ph |
| Applicant | URO PHARMACEUTICALS, INC. P.O. BOX 2073 Port Angeles, WA 98362 |
| Contact | Nicholas D Rotello |
| Correspondent | Nicholas D Rotello URO PHARMACEUTICALS, INC. P.O. BOX 2073 Port Angeles, WA 98362 |
| Product Code | LNW |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-05-24 |