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510(k) K942774

POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING by The Kendal Co. — Product Code MGP

K942774 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING". The FDA issued a decision of SN on July 20, 1994. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. The Kendal Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 20, 1994
Date Received
June 13, 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 The Kendal Co.

  • K000087 — MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR (March 17, 2000)
  • K990500 — KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY C (September 28, 1999)
  • K991758 — MONOJECT INSULIN SYRINGE (June 14, 1999)
  • K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (April 23, 1997)
  • K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP (April 25, 1995)
  • K942664 — KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM (January 17, 1995)
  • K892434 — KENDALL CURITY OXYGEN MASK (August 15, 1989)
  • K892438 — KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES (July 24, 1989)
  • K892440 — KENDALL CURITY EXTENSION TUBES (July 24, 1989)
  • K892436 — KENDALL CURITY IRRIGATION SYRINGE (July 14, 1989)

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