The following data is part of a premarket notification filed by Bioteque America, Inc. with the FDA for Flexible Silicone Gelihorn.
Device ID | K920187 |
510k Number | K920187 |
Device Name: | FLEXIBLE SILICONE GELIHORN |
Classification | Pessary, Vaginal |
Applicant | BIOTEQUE AMERICA, INC. 51 RAINLILY RD. Levittown, PA 19056 |
Contact | Denis Dorsey |
Correspondent | Denis Dorsey BIOTEQUE AMERICA, INC. 51 RAINLILY RD. Levittown, PA 19056 |
Product Code | HHW |
CFR Regulation Number | 884.3575 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-14 |
Decision Date | 1992-10-23 |