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510(k) K021969

CHROLOY by Neirynck & Vogt NV — Product Code EJH

K021969 is an FDA 510(k) premarket notification submitted by Neirynck & Vogt NV for the device "CHROLOY". The FDA issued a decision of Substantially Equivalent on July 30, 2002. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Neirynck & Vogt NV has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2002
Date Received
June 17, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type

Other clearances by Neirynck & Vogt NV

  • K023477 — BIOLOY (December 13, 2002)
  • K021971 — CERALOY (August 1, 2002)
  • K021968 — CERALOY SOLDER (July 26, 2002)
  • K021965 — CHROLOY SOLDER (July 26, 2002)

Other clearances for product code EJH

  • K123929 — BEGOPAL+ (March 14, 2013)
  • K040180 — CONTINUM V (March 4, 2004)
  • K040179 — CONTINUM (March 3, 2004)
  • K033356 — VERASOFT ES (December 30, 2003)
  • K033045 — DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST (December 23, 2003)
  • K032136 — WIROBOND C (September 4, 2003)
  • K031627 — NANO-TICROWN (June 11, 2003)
  • K030632 — PD CASTA-H (May 7, 2003)
  • K030416 — CERACAST-V (April 14, 2003)
  • K030161 — SUPERBOND (March 17, 2003)

FDA data resources