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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 K993147
Device Name DECAP
Applicant
The Kipp Group
930 Wanamaker Ave.
Ontario,  CA  91761
Applicant Contact GARY WERSCHMIDT
Correspondent
The Kipp Group
930 Wanamaker Ave.
Ontario,  CA  91761
Correspondent Contact GARY WERSCHMIDT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/21/1999
Decision Date 11/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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