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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 K924372
Device Name LAPAROSCOPIC NERVE HOOK
Applicant
Nusurg, Inc.
7432 Jager Ct.
Cincinnati,  OH  45230
Applicant Contact DENNIS R LACKEY
Correspondent
Nusurg, Inc.
7432 Jager Ct.
Cincinnati,  OH  45230
Correspondent Contact DENNIS R LACKEY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/28/1992
Decision Date 07/30/1993
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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