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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name holder, needle, gastroenterologic
510(k) Number K924196
Device Name LAPAROSCOPIC NEEDLE HOLDER
Applicant
NUSURG, INC.
7432 JAGER COURT
CINCINNATI,  OH  45230
Applicant Contact DENNIS R LACKEY
Correspondent
NUSURG, INC.
7432 JAGER COURT
CINCINNATI,  OH  45230
Correspondent Contact DENNIS R LACKEY
Regulation Number876.4730
Classification Product Code
FHQ  
Date Received08/20/1992
Decision Date 06/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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