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510(k) K960405

SPINAL NEEDLE by Promex, Inc. — Product Code MIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1996
Date Received
January 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Spinal, Short Term
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Promex, Inc.

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  • K011270 — AUTOMATED CORE BIOPSY DEVICE (June 22, 2001)
  • K001132 — BONE BIOPSY NEEDLE (May 1, 2000)
  • K994272 — AUTOMATED CORE BIOPSY DEVICE (January 7, 2000)
  • K993435 — MANUAL BONE MARROW BIOPSY DEVICE (December 6, 1999)
  • K973184 — PROSTATE SEEDING NEEDLE (November 21, 1997)
  • K972865 — PROMEX ENT TISSUE REMOVAL SYSTEM (September 29, 1997)
  • K961078 — AUTOMATED VITRECTOMY DEVICE (June 14, 1996)

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  • K982269 — CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND (July 23, 1998)
  • K971645 — REGANES SPINAL NEEDLE (VARIOUS) (August 1, 1997)
  • K970997 — NEO-CARE LUMBER PUNCTURE KIT (May 22, 1997)
  • K961324 — GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEED (July 2, 1996)
  • K942442 — ACUFEX T-FIX DELIVERY SYSTEM (December 5, 1994)
  • K904380 — SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM (April 8, 1993)