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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 K972984
Device Name LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE
Applicant
LERNER MEDICAL, INC.
840 WEST MAIN ST.
LANSDALE,  PA  19446
Applicant Contact MICHAEL POLLACK
Correspondent
LERNER MEDICAL, INC.
840 WEST MAIN ST.
LANSDALE,  PA  19446
Correspondent Contact MICHAEL POLLACK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/11/1997
Decision Date 10/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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