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510(k) K864969

JMS HALO APPLICATION TRAY by Jerome Medical — Product Code KDD

K864969 is an FDA 510(k) premarket notification submitted by Jerome Medical for the device "JMS HALO APPLICATION TRAY". The FDA issued a decision of Substantially Equivalent (with conditions) on February 18, 1987. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Jerome Medical has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
February 18, 1987
Date Received
December 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Jerome Medical

  • K051918 — RESOLVE OPEN BACK HALO RINGS (August 17, 2005)
  • K930021 — J TONGS (December 6, 1995)
  • K930153 — SYSTEM III HALO RING (August 6, 1993)
  • K882877 — JMS CERVICAL TRACTION DEVICE/HALO DEVICE (September 30, 1988)
  • K870053 — TORQUEDRIVER WRENCH (March 11, 1987)
  • K844490 — TRACTION ACCESSORIES (February 21, 1985)
  • K822780 — CERVICAL BRACE (October 6, 1982)
  • K821582 — WARM'N FORM SPORTS SUPPORTS (June 10, 1982)

Other clearances for product code KDD

  • K072814 — CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPA (April 16, 2008)
  • K011514 — INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (August 13, 2001)
  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)
  • K936255 — CUSTOM CV PACK (March 31, 1994)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K925905 — KIT, SURGICAL INSTRUMENT, DISPOSABLE (June 16, 1993)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)
  • K925215 — STERILE SURGICAL INSTRUMENT TRAYS (June 1, 1993)

FDA data resources