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510(k) K994022

PARALLAX CRANIOSET by Parallax Medical, Inc. — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2000
Date Received
November 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type

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  • K011206 — PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES (July 18, 2001)
  • K991893 — PARALLAX TRACER RADIOPAQUE PARTICLES (August 13, 1999)

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