The following data is part of a premarket notification filed by Roland J. Zwick, Inc. with the FDA for Dispo-urette.
| Device ID | K860796 |
| 510k Number | K860796 |
| Device Name: | DISPO-URETTE |
| Classification | Sampler, Endocervical |
| Applicant | ROLAND J. ZWICK, INC. 450 SAN ANTONION ROAD, STE. 21 Palo Alto, CA 94306 |
| Contact | Roland J Zwick |
| Correspondent | Roland J Zwick ROLAND J. ZWICK, INC. 450 SAN ANTONION ROAD, STE. 21 Palo Alto, CA 94306 |
| Product Code | PCF |
| CFR Regulation Number | 884.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-04-08 |