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510(k) K834560

VITEX P.D.A by Jeneric Ind. — Product Code EJH

K834560 is an FDA 510(k) premarket notification submitted by Jeneric Ind. for the device "VITEX P.D.A". The FDA issued a decision of Substantially Equivalent on February 27, 1984. 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
February 27, 1984
Date Received
December 28, 1983
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)
  • K840563 — RX C & B 20 (May 1, 1984)
  • K840561 — RX ELAN (May 1, 1984)
  • K840562 — REX V (April 13, 1984)
  • K833774 — NATURELLE II & LITE II-N72-N74-L (January 24, 1984)
  • K833736 — GOLD-PALLADIUM-SILVER BASED CAST/ALLOY (December 29, 1983)

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