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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K923726
Device Name KENSEY NASH DYNAMIC CLIP SYSTEM
Applicant
Kensey Nash Corp.
55 E. Uwchlan Ave.
Marsh Creek Corp. Center
Exton,  PA  19341
Applicant Contact SPRIEGEL
Correspondent
Kensey Nash Corp.
55 E. Uwchlan Ave.
Marsh Creek Corp. Center
Exton,  PA  19341
Correspondent Contact SPRIEGEL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/27/1992
Decision Date 04/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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