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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Urethral Occluder, Urinary Incontinence-Control, Female
510(k) Number K974645
Device Name FEMASSIST FLEXIBLE
Applicant
Insight Medical Corp.
580 Main St.
Bolton,  MA  01740
Applicant Contact MICHAEL G VERGANO
Correspondent
Insight Medical Corp.
580 Main St.
Bolton,  MA  01740
Correspondent Contact MICHAEL G VERGANO
Regulation Number876.5160
Classification Product Code
MNG  
Date Received12/12/1997
Decision Date 02/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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