The following data is part of a premarket notification filed by Medi-source, Inc. with the FDA for Gellhorn Pessary 33410 Various Sizes.
| Device ID | K890565 |
| 510k Number | K890565 |
| Device Name: | GELLHORN PESSARY 33410 VARIOUS SIZES |
| Classification | Pessary, Vaginal |
| Applicant | MEDI-SOURCE, INC. 50 GORDON DR. P.O. BOX 874 Syosset, NY 11791 |
| Contact | Andrew Galambos |
| Correspondent | Andrew Galambos MEDI-SOURCE, INC. 50 GORDON DR. P.O. BOX 874 Syosset, NY 11791 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-03-29 |