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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 K770711
Device Name TROCAR SLEEVE SYSTEM, 6.5MM TO 5.0MM
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/18/1977
Decision Date 04/26/1977
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
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