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510(k) K910652

SPINAL TAP NEEDLE by Gesco Intl., Inc. — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1991
Date Received
February 14, 1991
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 Gesco Intl., Inc.

  • K954422 — PER-Q-CATH MID-LINE (December 15, 1995)
  • K940953 — UMBILI-CATH-S (August 2, 1994)
  • K940870 — UMBILI-CATH (August 2, 1994)
  • K940952 — UMBILI-CATH-S-DL (July 29, 1994)
  • K941672 — URI-CATH CATHETER (May 16, 1994)
  • K941232 — THORA-CATH (May 11, 1994)
  • K940871 — UMBILI-CATH-P (April 29, 1994)
  • K931989 — VENTRI-CATH (July 21, 1993)
  • K926063 — PER-Q-CATH DRESSING CHANGE TRAY (June 7, 1993)
  • K923591 — PALA-NATE (March 16, 1993)

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  • K241954 — SonoBlock; SonoBlock II (September 11, 2024)
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