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510(k) K964398

SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED by Polymedica Industries, Inc. — Product Code MGP

K964398 is an FDA 510(k) premarket notification submitted by Polymedica Industries, Inc. for the device "SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED". The FDA issued a decision of Substantially Equivalent on October 24, 1997. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Polymedica Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1997
Date Received
November 4, 1996
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 Polymedica Industries, Inc.

  • K971045 — BASIS FLEXIBLE TIP DIGITAL THERMOMETER (May 2, 1997)
  • K964701 — MITRAFLEX PIGMENTED WOUND DRESSING (February 7, 1997)
  • K963623 — SPYROFLEX PIGMENTED WOUND DRESSING (October 25, 1996)
  • K962991 — BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER (September 12, 1996)
  • K955383 — SPYROCOLLOID WOUND DRESSING (December 13, 1995)
  • K953885 — SPYROFLEX SKIN PROTECTOR (November 29, 1995)
  • K952756 — MEDI-AID BASAL THERMOMETER (September 25, 1995)
  • K952159 — BASIS DIGITAL THERMOMETER (September 22, 1995)
  • K953618 — SPYROFLEX WOUND DRESSING (August 21, 1995)
  • K951862 — A GEL WOUND DRESSING (July 12, 1995)

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