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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 K944870
Device Name JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680
Applicant
J. Jamner Surgical Instruments, Inc.
9 Skyline Dr.
Hawthorne,  NY  10532
Applicant Contact PATRICE E DOWNEY
Correspondent
J. Jamner Surgical Instruments, Inc.
9 Skyline Dr.
Hawthorne,  NY  10532
Correspondent Contact PATRICE E DOWNEY
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
GCM  
Date Received09/22/1994
Decision Date 11/02/1994
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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