The following data is part of a premarket notification filed by Bioteque America, Inc. with the FDA for Pessary Flexible Silicone Nichols.
| Device ID | K920633 |
| 510k Number | K920633 |
| Device Name: | PESSARY FLEXIBLE SILICONE NICHOLS |
| Classification | Stent, Vaginal |
| Applicant | BIOTEQUE AMERICA, INC. 340 E. MAPLE AVE. SUITE 102 Langhorne, PA 19047 |
| Contact | Dennis Dorsey |
| Correspondent | Dennis Dorsey BIOTEQUE AMERICA, INC. 340 E. MAPLE AVE. SUITE 102 Langhorne, PA 19047 |
| Product Code | KXP |
| CFR Regulation Number | 884.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-12 |
| Decision Date | 1995-11-08 |