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510(k) K903485

TITANIUM MESH by Ruggles Corp. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1991
Date Received
July 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Alterable
Device Class
Class II
Regulation Number
882.5320
Review Panel
NE
Submission Type

Other clearances by Ruggles Corp.

  • K902818 — MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT (September 20, 1990)
  • K902819 — LAMINECTOMY ROGEUR (August 9, 1990)
  • K902850 — ZEPPELIN INSTRUMENTS (July 18, 1990)
  • K893415 — TRANS-ORAL DEPTH GAUGE (June 7, 1989)

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