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510(k) K002063

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

K002063 is an FDA 510(k) premarket notification submitted by Bryan Corp. for the device "BIOTRACE, MODEL 1730". The FDA issued a decision of Substantially Equivalent on August 10, 2000. The device falls under product code MYU (Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Bryan Corp. has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code MYU

  • K033230 — TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA (December 12, 2003)
  • K032388 — BONE CEMENT RADIO-OPACIFIER (October 31, 2003)
  • K024359 — VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 (August 8, 2003)
  • K023445 — TRACERS BONE CEMENT OPACIFIER (March 11, 2003)
  • K991893 — PARALLAX TRACER RADIOPAQUE PARTICLES (August 13, 1999)

FDA data resources