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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K933728
Device Name JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339
Applicant
J. Jamner Surgical Instruments, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
J. Jamner Surgical Instruments, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/02/1993
Decision Date 02/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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