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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K902109
Device Name STATLOCK IV CONNECTOR AND ANCHOR SET
Applicant
Venetec, Inc.
1250 S. Parker Rd.
Suite 204, P.O. Box 6510
Denver,  CO  80206
Applicant Contact DAVID C HOWSON
Correspondent
Venetec, Inc.
1250 S. Parker Rd.
Suite 204, P.O. Box 6510
Denver,  CO  80206
Correspondent Contact DAVID C HOWSON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/09/1990
Decision Date 10/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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