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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 K924931
Device Name NEEDLE, PNEUMOPERITONEUM, SPRING LOADED
Applicant
Lpc, Inc.
7123 Industrial Park Blvd.
Mentor,  OH  44060
Applicant Contact LISA SCHOLZ
Correspondent
Lpc, Inc.
7123 Industrial Park Blvd.
Mentor,  OH  44060
Correspondent Contact LISA SCHOLZ
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/30/1992
Decision Date 05/17/1993
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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