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Hart Enterprises, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
4
Inspections
3
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K921683
PENCIL POINT SPINAL NEEDLE
August 26, 1993
K913815
AUTOMATED BIOPSY DEVICE, MODIFICATION
October 30, 1991
K885149
NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE
January 26, 1989
K881730
BREAST LOCALIZATION NEEDLES
May 13, 1988