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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 K943038
Device Name STATLOCK-IPIDURAL
Applicant
Venetec, Inc.
1500 Quail St.
Suite 550
Newport Beach,  CA  92660
Applicant Contact PATRICIA AMTOWER
Correspondent
Venetec, Inc.
1500 Quail St.
Suite 550
Newport Beach,  CA  92660
Correspondent Contact PATRICIA AMTOWER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/27/1994
Decision Date 04/10/1995
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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