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510(k) K952363

OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) by Ela Medical, Inc. — Product Code ELA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1995
Date Received
May 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Hand, Calculus Removal
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Ela Medical, Inc.

  • K042002 — SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER (October 20, 2004)
  • K032466 — SPIDERVIEW (August 22, 2003)
  • K002817 — SYNETEC (May 2, 2001)
  • K993448 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHA (April 10, 2000)
  • K000029 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHA (April 4, 2000)
  • K990727 — SYNEFLASH & SYNEVIEW (November 26, 1999)
  • K972574 — STELA MODEL UJ45 PACING LEADS (January 8, 1998)
  • K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS (August 29, 1997)
  • K963738 — STELA MODEL BJ44 AND BJ45 PACING LEADS (May 23, 1997)
  • K952364 — OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (September 1, 1995)

Other clearances for product code ELA

  • K854168 — TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES (March 13, 1986)
  • K823326 — DENTAL INSTRUMENTS - CUTTING INSTRUMENT (November 24, 1982)
  • K801974 — ANALYTIC TECH. METAL POINT HEATER #3001 (November 12, 1980)