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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 K955792
Device Name WILO SERIES SECUR, AUTOMATIC TROCAR SET, TROCAR, CONICAL, TRIANGULAR GROUND, SAFETY W/OUT LOCK, SET OF SUCTION - IRRIGA0
Applicant
Wilo Medizintechnik Lothar Wilberg GmbH
2550 M St. NW
Washington,  DC  20037
Applicant Contact MARK HELLER
Correspondent
Wilo Medizintechnik Lothar Wilberg GmbH
2550 M St. NW
Washington,  DC  20037
Correspondent Contact MARK HELLER
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
GCJ  
Date Received12/22/1995
Decision Date 07/26/1996
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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