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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 K971359
Device Name RESTORE (A.K.A. CAPSURE)
Applicant
Nebl, Inc.
44 Terrace Dr.
Worcester,  MA  01609
Applicant Contact JEFFREY A DANN
Correspondent
Nebl, Inc.
44 Terrace Dr.
Worcester,  MA  01609
Correspondent Contact JEFFREY A DANN
Regulation Number876.5160
Classification Product Code
MNG  
Date Received04/11/1997
Decision Date 11/14/1997
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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