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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 K021999
Device Name GRIPPER PLUS NEEDLE
Applicant
Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact LISA STONE
Correspondent
Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact LISA STONE
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FMI  
Date Received06/19/2002
Decision Date 08/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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