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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K932456
Device Name JARIT SURGICAL INSTRUMENTS
Applicant
J. Jamner Surgical Instruments, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact BENEKE JR.
Correspondent
J. Jamner Surgical Instruments, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact BENEKE JR.
Regulation Number884.4160
Classification Product Code
KNF  
Date Received05/21/1993
Decision Date 04/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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