The following data is part of a premarket notification filed by Eschmann Bros. & Walsh Ltd. with the FDA for Device, Female Incontinence.
Device ID | K781863 |
510k Number | K781863 |
Device Name: | DEVICE, FEMALE INCONTINENCE |
Classification | Pessary, Vaginal |
Applicant | ESCHMANN BROS. & WALSH LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HHW |
CFR Regulation Number | 884.3575 [🔎] |
Decision | Se - Postmarket Surveillance Required (SESP) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-11-06 |
Decision Date | 1978-11-06 |