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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Intestine
510(k) Number K913678
Device Name TROCAR CATHETER
Applicant
Medovations, Inc.
102 E. Keefe Ave.
Milwaukee,  WI  53212
Applicant Contact BRIAN E LARSON
Correspondent
Medovations, Inc.
102 E. Keefe Ave.
Milwaukee,  WI  53212
Correspondent Contact BRIAN E LARSON
Regulation Number878.4100
Classification Product Code
KGY  
Date Received08/19/1991
Decision Date 12/16/1991
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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