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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 K002877
Device Name MICTEC ENDOSCOPES AND ACCESSORIES
Applicant
Dufner Instrumente GmbH
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Applicant Contact DAGMAR MASER
Correspondent
Dufner Instrumente GmbH
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Correspondent Contact DAGMAR MASER
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
GCJ   HET  
Date Received09/15/2000
Decision Date 02/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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