The following data is part of a premarket notification filed by Bioteque America, Inc. with the FDA for Bioteque Vaginal Dilator.
| Device ID | K003380 |
| 510k Number | K003380 |
| Device Name: | BIOTEQUE VAGINAL DILATOR |
| Classification | Dilator, 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 | HDX |
| CFR Regulation Number | 884.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-31 |
| Decision Date | 2001-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30649111062630 | K003380 | 000 |
| 00810142352222 | K003380 | 000 |
| 00810142352239 | K003380 | 000 |
| 00810142352246 | K003380 | 000 |
| 00810142352260 | K003380 | 000 |
| 00810142352277 | K003380 | 000 |
| 00810142352284 | K003380 | 000 |
| 00810142352291 | K003380 | 000 |
| 00810142352314 | K003380 | 000 |
| 00810142352253 | K003380 | 000 |
| 10381780169918 | K003380 | 000 |
| 10381780169925 | K003380 | 000 |
| 10381780169932 | K003380 | 000 |
| 30649111061916 | K003380 | 000 |
| 30649111062364 | K003380 | 000 |
| 00810142352215 | K003380 | 000 |