The following data is part of a premarket notification filed by Hoosier Specialties, Inc. with the FDA for Word Bartholin Gland Catheter Code: 1005.
| Device ID | K880497 |
| 510k Number | K880497 |
| Device Name: | WORD BARTHOLIN GLAND CATHETER CODE: 1005 |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | HOOSIER SPECIALTIES, INC. RURAL ROUTE #5 POST OFFICE BOX 424 Sullivan, IN 47882 |
| Contact | Sherry Parr |
| Correspondent | Sherry Parr HOOSIER SPECIALTIES, INC. RURAL ROUTE #5 POST OFFICE BOX 424 Sullivan, IN 47882 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-05 |
| Decision Date | 1988-03-24 |