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510(k) K881730

BREAST LOCALIZATION NEEDLES by Hart Enterprises, Inc. — Product Code GDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1988
Date Received
April 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Reusable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Hart Enterprises, Inc.

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  • K913815 — AUTOMATED BIOPSY DEVICE, MODIFICATION (October 30, 1991)
  • K885149 — NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE (January 26, 1989)

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  • K936207 — ENDO-NEEDLE INSTRUMENT (June 16, 1994)
  • K930160 — ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE (July 6, 1993)
  • K923872 — BONE MARROW BIOPSY SYSTEM (December 15, 1992)
  • K915572 — BECTON DICKINSON MODIFIED MENGHINI NEEDLE (February 3, 1992)
  • K904667 — NA NEEDLES (December 12, 1990)
  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)