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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 K944706
Device Name REDA LAPAROSCOPIC INSTRUMENTS GER-MAIN PRIME ENDO LAPAROSCOPIC INSTRUMENTS
Applicant
Reda Instrumente GmbH
Ringstr. 23
Tuttlingen,  DE 78532
Applicant Contact KARL HUBER
Correspondent
Reda Instrumente GmbH
Ringstr. 23
Tuttlingen,  DE 78532
Correspondent Contact KARL HUBER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/23/1994
Decision Date 10/20/1994
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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