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510(k) K002063

BIOTRACE, MODEL 1730 by Bryan Corp. — Product Code MYU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2000
Date Received
July 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Bryan Corp.

  • K913242 — MICROPROCESSED CONTROLLED LAPAROFLATOR (September 25, 1992)
  • K894380 — DUMON TRACHEOBRONCHIAL STENT (October 24, 1989)
  • K881249 — BAGGISH, HYSTEROSCOPE (July 28, 1988)
  • K854414 — DUMON/HARRELL (March 12, 1986)

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  • K023445 — TRACERS BONE CEMENT OPACIFIER (March 11, 2003)
  • K991893 — PARALLAX TRACER RADIOPAQUE PARTICLES (August 13, 1999)