Home / 510(k) Clearances / K844123

510(k) K844123

RX CBY by Jeneric Ind. — Product Code EJH

K844123 is an FDA 510(k) premarket notification submitted by Jeneric Ind. for the device "RX CBY". The FDA issued a decision of Substantially Equivalent on Jan 9, 1985. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Jeneric Ind. has 24 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 9, 1985
Date Received
Oct 23, 1984
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
510(k) Exempt

Other clearances by Jeneric Ind.

  • K862822 — REXILLIUM N. B. F. (Sep 2, 1986)
  • K862926 — SURGICAL VITEX (Aug 29, 1986)
  • K854878 — H40 BASE METAL ALLOY (Jan 30, 1986)
  • K844122 — RX CBG (Jan 9, 1985)
  • K840563 — RX C & B 20 (May 1, 1984)
  • K840561 — RX ELAN (May 1, 1984)
  • K840562 — REX V (Apr 13, 1984)
  • K834560 — VITEX P.D.A (Feb 27, 1984)
  • K833774 — NATURELLE II & LITE II-N72-N74-L (Jan 24, 1984)
  • K833736 — GOLD-PALLADIUM-SILVER BASED CAST/ALLOY (Dec 29, 1983)

Other clearances for product code EJH

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

FDA data resources