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510(k) K902818

MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT by Ruggles Corp. — Product Code HBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1990
Date Received
June 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Manual)
Device Class
Class II
Regulation Number
882.4300
Review Panel
NE
Submission Type

Other clearances by Ruggles Corp.

  • K903485 — TITANIUM MESH (February 21, 1991)
  • K902819 — LAMINECTOMY ROGEUR (August 9, 1990)
  • K902850 — ZEPPELIN INSTRUMENTS (July 18, 1990)
  • K893415 — TRANS-ORAL DEPTH GAUGE (June 7, 1989)

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  • K160129 — MRII Cranial Drill and Accessories (March 26, 2016)
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  • K122456 — MRII CRAINIAL DRILL (March 22, 2013)
  • K022712 — HAND DRILL, MODEL 11-9901-7 (November 12, 2002)
  • K022370 — FRAMELOCK; FRAMELOCK ACCESSORIES (October 18, 2002)
  • K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILL (June 5, 1996)
  • K932402 — MODIFICATION TO GHAJAR GUIDE TWIST DRILL (August 5, 1993)