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510(k) K960082

DISCOGRAPHY KIT by Spinal Specialties, Inc. — Product Code IZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1996
Date Received
January 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Photofluorographic
Device Class
Class II
Regulation Number
892.1730
Review Panel
RA
Submission Type

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  • K950820 — SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE (June 30, 1995)
  • K944029 — CONTINUOUS EPIDURAL ANESTHESIA TRAY (June 30, 1995)
  • K941343 — SPINAL ANESTHESIA TRAY (August 11, 1994)
  • K935245 — EPIDURAL ANESTHESIA TRAY (May 2, 1994)

Other clearances for product code IZG

  • K960146 — G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY (February 27, 1996)
  • K913436 — PXI PNEUMATIC COMPRESSION PADDLE (November 5, 1992)
  • K920393 — MU125M MOBILE X-RAY SYSTEM (April 6, 1992)
  • K910503 — DISCOGRAPHY KIT (October 7, 1991)
  • K903808 — AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT (January 22, 1991)
  • K892659 — ELECTRODELCA (November 21, 1989)