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510(k) K921950

SURGICAL DYNAMICS DISCOGRAPHY SYSTEM by Surgical Dynamics, Inc. — Product Code FMI

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 7, 1993
Date Received
April 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Surgical Dynamics, Inc.

  • K960046 — SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE (April 2, 1996)
  • K942987 — NUCLEOTOME L KIT (October 30, 1995)
  • K954193 — SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET (October 23, 1995)
  • K950495 — SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 (May 9, 1995)
  • K931109 — NUCLEOTOME E KIT (March 29, 1994)
  • K923525 — NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR (February 9, 1993)
  • K913145 — NUCLEOTOME TISSUE ASPIRATOR/CUTTER (December 19, 1991)
  • K914282 — NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER (December 19, 1991)
  • K902778 — SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER (October 30, 1990)
  • K894336 — SURGICAL DYNAMICS DISCOGRAPHY SYSTEM (August 4, 1989)

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