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510(k) K860018

FISCHER WIRE/PIN CLAMP by Buckman Co., Inc. — Product Code HXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1986
Date Received
January 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Needle; Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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  • K950999 — KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS (January 25, 1996)
  • K945756 — IMAGN(TM) 2000 SYSTEM (December 19, 1995)
  • K940003 — VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (October 19, 1995)
  • K951117 — LIHTAN 532 LASER (October 18, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)

Other clearances for product code HXK

  • K890167 — HOLDER, NEEDLE (February 3, 1989)
  • K872989 — MICRINS NEEDLE HOLDER (August 21, 1987)
  • K801594 — ACE FISCHER EXTERNAL FIXATION DEVICE (September 9, 1980)
  • K772388 — CONVERSE-GILLIES NEEDLE HOLDER (January 20, 1978)