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510(k) K921683

PENCIL POINT SPINAL NEEDLE by Hart Enterprises, Inc. — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1993
Date Received
April 8, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Hart Enterprises, Inc.

  • 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)

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