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510(k) K911649

MITRASHEER TRANSPLANT DRESSING by Polymint Industrial Co. , Ltd. — Product Code MGP

K911649 is an FDA 510(k) premarket notification submitted by Polymint Industrial Co. , Ltd. for the device "MITRASHEER TRANSPLANT DRESSING". The FDA issued a decision of Substantially Equivalent on August 7, 1991. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Polymint Industrial Co. , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1991
Date Received
April 12, 1991
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 Polymint Industrial Co. , Ltd.

  • K932457 — SPYROGEL WOUND DRESSING (February 9, 1994)
  • K931634 — VARIOUS KITS (November 30, 1993)
  • K921775 — SPYROFLEX WOUND CLOSURES (May 19, 1992)
  • K891644 — SAMBORD LATEX PATIENT EXAMINATION GLOVES (June 19, 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