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510(k) K980536

EPIDURAL NEEDLE by Manan Medical Products, Inc. — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1998
Date Received
February 11, 1998
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 Manan Medical Products, Inc.

  • K052802 — MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE (November 1, 2005)
  • K011209 — MANAN SPRITACRE SPINAL NEEDLES (June 26, 2001)
  • K983620 — MANAN SPINAL NEEDLES (January 8, 1999)
  • K981386 — MANAN BLUNT NEEDLE (June 29, 1998)
  • K980211 — MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES (February 6, 1998)
  • K974446 — MANAN AUTOMATIC CUTTING NEEDLE (January 8, 1998)
  • K962977 — MRI COMPATIBLE BIOPSY NEEDLES (October 9, 1997)
  • K963767 — MANAN V.S. ACCESS NEEDLE/SET (May 16, 1997)
  • K961986 — MANAN D BAG (March 13, 1997)
  • K962001 — MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE (January 10, 1997)

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