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510(k) K012303

JEL-20 by J.F. Jelenko & Co., Inc. — Product Code EJS

K012303 is an FDA 510(k) premarket notification submitted by J.F. Jelenko & Co., Inc. for the device "JEL-20". The FDA issued a decision of Substantially Equivalent on August 22, 2001. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. J.F. Jelenko & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2001
Date Received
July 20, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Other Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by J.F. Jelenko & Co., Inc.

  • K002993 — HERACERAM (November 16, 2000)
  • K002645 — JEL BIOS PURE (October 19, 2000)
  • K002222 — RD-2104 (August 31, 2000)
  • K001360 — SIGNUM (June 20, 2000)
  • K001260 — ALLROUND 55 LF (May 17, 2000)
  • K001196 — JEL BIOS 90 (CODE NAME RD-2401) (May 11, 2000)
  • K000532 — JEL 15 (April 6, 2000)
  • K993152 — JEL BIOS 18 (CODE NAME RD- 1214) (October 21, 1999)
  • K993136 — JEL BIOS 10 (CODE NAME RD-1801) (October 21, 1999)
  • K991564 — JELTEMP (June 23, 1999)

Other clearances for product code EJS

  • K041433 — BRIGHT GOLD XH (August 19, 2004)
  • K040436 — SIMIDUR SUPERIOR (March 5, 2004)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K022469 — ECO E4 (September 18, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020192 — SIMIDUR S2 (March 15, 2002)
  • K020195 — SIMIDUR S1S (March 15, 2002)
  • K020194 — SIMIDUR KF PLUS (March 15, 2002)
  • K014042 — D.SIGN 84 (February 22, 2002)
  • K013809 — D.SIGN 59 (February 7, 2002)

FDA data resources