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510(k) K941625

DW234 #29 by Rms Div. — Product Code EJS

K941625 is an FDA 510(k) premarket notification submitted by Rms Div. for the device "DW234 #29". The FDA issued a decision of Substantially Equivalent on June 22, 1994. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Rms Div. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1994
Date Received
April 4, 1994
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 Rms Div.

  • K963367 — RMS K-WIRE (October 30, 1996)
  • K954438 — SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE (December 29, 1995)
  • K944848 — THE VIVACARE T.P.S. PROBE (December 14, 1994)
  • K944557 — DW250 #91 (November 3, 1994)
  • K902403 — ELITE R/F SPOT FILM DRIVE (August 1, 1990)
  • K902146 — SFD-035 SPOT FILM DEVICE (May 31, 1990)
  • K896665 — EXT-600 TABLE, RADIOGRAPHIC, ELEVATING (January 22, 1990)
  • K896119 — RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE (November 27, 1989)
  • K896324 — ELITE 1500 RADIOGRAPHIC TILTING TABLE (November 21, 1989)

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