The following data is part of a premarket notification filed by Bioteque America, Inc. with the FDA for Bioteque Vaginal Pessaries.
| Device ID | K013289 |
| 510k Number | K013289 |
| Device Name: | BIOTEQUE VAGINAL PESSARIES |
| Classification | Pessary, Vaginal |
| Applicant | BIOTEQUE AMERICA, INC. 340 EAST MAPLE AVE., #204-C Langhorne, PA 19047 |
| Contact | Denis Dorsey |
| Correspondent | Denis Dorsey BIOTEQUE AMERICA, INC. 340 EAST MAPLE AVE., #204-C Langhorne, PA 19047 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-02 |
| Decision Date | 2001-12-27 |