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510(k) K932219

SUTURE SET OR LACERATION TRAYS (PACKS) by Associated Medical Products Co. — Product Code KDD

K932219 is an FDA 510(k) premarket notification submitted by Associated Medical Products Co. for the device "SUTURE SET OR LACERATION TRAYS (PACKS)". The FDA issued a decision of Substantially Equivalent (kit) on July 9, 1993. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Associated Medical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
July 9, 1993
Date Received
May 7, 1993
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 Associated Medical Products Co.

  • K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS) (March 19, 1997)
  • K932216 — C-SECTION, LABOR & DELIVERY TRAYS (PACKS) (April 19, 1994)
  • K930507 — CUSTOM ORTHOPAEDIC TRAYS (PACKS) (February 22, 1994)
  • K932217 — MAJOR, MINOR, BASIN TRAYS (PACKS) (November 15, 1993)
  • K932220 — LAP CHOLY TRAYS (PACKS) (September 27, 1993)
  • K932218 — CARDIAC CATH OR ANGIOGRAPHIC TRAYS (August 27, 1993)
  • K842983 — AMPCO OPTHALMIC TRAY (May 22, 1985)
  • K843114 — AMPCO PROCEDURE TRAYS / PACKS (August 8, 1984)
  • K823839 — AMPCO KIDNEY DIALYSIS TRAY (March 29, 1983)
  • K821579 — SKIN SCRUB-TRAY (July 21, 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)
  • 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)

FDA data resources