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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 K931878
Device Name JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680
Applicant
J. JAMNER SURGICAL INSTRUMENTS, INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Applicant Contact KOTULA COOK
Correspondent
J. JAMNER SURGICAL INSTRUMENTS, INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Correspondent Contact KOTULA COOK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/14/1993
Decision Date 08/19/1993
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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