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510(k) K943424

CUSH ISLAND DRESSING by Cush Medical Products — Product Code MGP

K943424 is an FDA 510(k) premarket notification submitted by Cush Medical Products for the device "CUSH ISLAND DRESSING". The FDA issued a decision of SN on October 3, 1994. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Cush Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
October 3, 1994
Date Received
July 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Occlusive
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Cush Medical Products

  • K940518 — C-SECTION TRAY (August 18, 1994)
  • K941349 — DENTAL TRAY (July 26, 1994)
  • K941645 — BIOPSY TRAY (July 14, 1994)
  • K940239 — EYE TRAY (June 28, 1994)
  • K935684 — IV START KIT (June 10, 1994)
  • K941455 — STERILE GAUZE PRODUCT LINE (May 20, 1994)
  • K941344 — LAP SPONGE PRODUCT LINE (May 12, 1994)
  • K941522 — STERILE X-RAY DETECTABLE GAUZE SPONGES (May 12, 1994)
  • K935697 — CIRCUMCISION TRAY (May 2, 1994)
  • K936120 — LABOR AND DELIVERY TRAY (March 30, 1994)

Other clearances for product code MGP

  • K012995 — COLLATEK SHEET (October 25, 2001)
  • K012997 — COLLATEK FOAM (October 25, 2001)
  • K001508 — LASERSKIN DRESSING (July 25, 2001)
  • K990079 — FASTSEAL CHEST WOUND DRESSING (December 23, 1999)
  • K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING (October 14, 1999)
  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (September 14, 1999)
  • K992005 — GILTECH PLUS TRANSPARENT DRESSING (September 3, 1999)
  • K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (May 27, 1999)
  • K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSI (March 25, 1999)
  • K984371 — MEPITEL NON ADHERENT SILICONE DRESSING (March 3, 1999)

FDA data resources