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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pessary, Vaginal
510(k) Number K781863
Device Name DEVICE, FEMALE INCONTINENCE
Applicant
Eschmann Bros. & Walsh , Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Eschmann Bros. & Walsh , Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.3575
Classification Product Code
HHW  
Date Received11/06/1978
Decision Date 11/06/1978
Decision SE - Postmarket Surveillance Required (SESP)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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