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510(k) K932676

SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER) by Polymedica Industries, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1993
Date Received
June 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Polymedica Industries, Inc.

  • K964398 — SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED (October 24, 1997)
  • 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)

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