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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 K924028
Device Name LAPAROSCOPIC SURGICAL INSTRUMENT
Applicant
Jana Medical
Rt. 507
Box J
Greentown,  PA  18426
Correspondent
Jana Medical
Rt. 507
Box J
Greentown,  PA  18426
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
GCJ  
Date Received08/11/1992
Decision Date 06/18/1993
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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