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510(k) K944557

DW250 #91 by Rms Div. — Product Code EJT

K944557 is an FDA 510(k) premarket notification submitted by Rms Div. for the device "DW250 #91". The FDA issued a decision of Substantially Equivalent on November 3, 1994. The device falls under product code EJT (Alloy, Gold-Based 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
November 3, 1994
Date Received
September 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based 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)
  • K941625 — DW234 #29 (June 22, 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 EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)

FDA data resources