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 |