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510(k) K971317

NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS by National Healthcare Mfg. Corp. — Product Code KDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1997
Date Received
April 9, 1997
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 National Healthcare Mfg. Corp.

  • K972013 — NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS (August 26, 1997)
  • K971465 — NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS (June 4, 1997)
  • K962670 — NHMC IRRIGATION TRAY (August 14, 1996)
  • K962254 — NHMC URETHRAL CATHETERIZATION TRAY (July 29, 1996)
  • K960523 — NHMC DRESSING TRAY (April 4, 1996)
  • K960566 — NHMC FOLEY CATHETERIZATION TRAY (February 29, 1996)

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)
  • 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)
  • K924117 — DEXIDE LAPAROSCOPIC KITS (March 23, 1993)