Home / 510(k) Clearances / K031627

510(k) K031627

NANO-TICROWN by Nano-Write Corp. — Product Code EJH

K031627 is an FDA 510(k) premarket notification submitted by Nano-Write Corp. for the device "NANO-TICROWN". The FDA issued a decision of Substantially Equivalent on June 11, 2003. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2003
Date Received
May 27, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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)
  • K030632 — PD CASTA-H (May 7, 2003)
  • K030416 — CERACAST-V (April 14, 2003)
  • K030161 — SUPERBOND (March 17, 2003)
  • K024214 — KAVO EVEREST TITANBLANK (March 12, 2003)

FDA data resources