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510(k) K823008

NOVAREX by Jeneric Ind. — Product Code EJH

K823008 is an FDA 510(k) premarket notification submitted by Jeneric Ind. for the device "NOVAREX". The FDA issued a decision of Substantially Equivalent on November 3, 1982. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Jeneric Ind. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1982
Date Received
October 12, 1982
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 Jeneric Ind.

  • K862822 — REXILLIUM N. B. F. (September 2, 1986)
  • K862926 — SURGICAL VITEX (August 29, 1986)
  • K854878 — H40 BASE METAL ALLOY (January 30, 1986)
  • K844123 — RX CBY (January 9, 1985)
  • K844122 — RX CBG (January 9, 1985)
  • K840561 — RX ELAN (May 1, 1984)
  • K840563 — RX C & B 20 (May 1, 1984)
  • K840562 — REX V (April 13, 1984)
  • K834560 — VITEX P.D.A (February 27, 1984)
  • K833774 — NATURELLE II & LITE II-N72-N74-L (January 24, 1984)

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