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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Penile
510(k) Number K954959
Device Name CAP-AID
Applicant
Nebl, Inc.
44 Ter. Dr.
Worcester,  MA  01609
Applicant Contact JEFFREY A DANN
Correspondent
Nebl, Inc.
44 Ter. Dr.
Worcester,  MA  01609
Correspondent Contact JEFFREY A DANN
Regulation Number876.5160
Classification Product Code
FHA  
Date Received10/27/1995
Decision Date 12/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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