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510(k) K041978

REPROCESSED DIAMOND BURS by Alliance Medical Corp. — Product Code NLN

K041978 is an FDA 510(k) premarket notification submitted by Alliance Medical Corp. for the device "REPROCESSED DIAMOND BURS". The FDA issued a decision of Substantially Equivalent on November 23, 2004. The device falls under product code NLN (Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed), a Class II device regulated under 21 CFR 882.4310. Alliance Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2004
Date Received
July 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
Device Class
Class II
Regulation Number
882.4310
Review Panel
NE
Submission Type

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Alliance Medical Corp.

  • K060648 — REPROCESSED PHACOEMULSIFICATION TIPS (March 19, 2007)
  • K061045 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (August 31, 2006)
  • K051438 — VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) (April 4, 2006)
  • K060049 — REPROCESSED COMPRESSION SLEEVES (February 24, 2006)
  • K060091 — ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES (February 17, 2006)
  • K053316 — REPROCESSED COMPRESSION SLEEVES (February 13, 2006)
  • K052918 — REPROCESSED EXTERNAL FIXATION DEVICES (January 27, 2006)
  • K052603 — REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS (November 16, 2005)
  • K052414 — REPROCESSED ELECTROPHYSIOLOGY CATHETER (November 16, 2005)
  • K050518 — REPROCESSED PHACOEMUISIFICATION TIPS (September 23, 2005)

FDA data resources