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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 K926078
Device Name DMI TOCAR AND CANNULA SYSTEM
Applicant
DIVERSIFIED MEDICAL INSTRUMENTS, INC.
4519 TARALEY COURT
ELLICOTT CITY,  MD  21042
Applicant Contact CHARLES J SALBERG
Correspondent
DIVERSIFIED MEDICAL INSTRUMENTS, INC.
4519 TARALEY COURT
ELLICOTT CITY,  MD  21042
Correspondent Contact CHARLES J SALBERG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/01/1992
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
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