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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 K964580
Device Name CAP-AID (IMPROVED)
Applicant
Nebel, Inc.
44 Ter. Dr.
Worcester,  MA  01609
Applicant Contact JEFFREY A DANN, M.D.
Correspondent
Nebel, Inc.
44 Ter. Dr.
Worcester,  MA  01609
Correspondent Contact JEFFREY A DANN, M.D.
Regulation Number876.5160
Classification Product Code
FHA  
Date Received11/15/1996
Decision Date 01/10/1997
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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