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510(k) K983081

BEGOPAL 300 by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO — Product Code EJS

K983081 is an FDA 510(k) premarket notification submitted by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO for the device "BEGOPAL 300". The FDA issued a decision of Substantially Equivalent on October 28, 1998. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1998
Date Received
September 2, 1998
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 Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO

  • K132102 — BECE CAD ZIRKON HT+ (November 12, 2013)
  • K123929 — BEGOPAL+ (March 14, 2013)
  • K090434 — BECE PRESS (July 6, 2009)

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)
  • K020195 — SIMIDUR S1S (March 15, 2002)
  • K020192 — SIMIDUR S2 (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