GRIPPER PLUS NEEDLE


Device Classification Name

set, administration, intravascular

510(k) Number K021999
Device Name GRIPPER PLUS NEEDLE
Original Applicant
DELTEC, INC.
1265 grey fox rd.
st. paul, 
MN 
55112

Original Contact lisa stone
Regulation Number 880.5440
Classification Product Code
FPA  
Subsequent Product Code
FMI  
Date Received 06/19/2002
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