Home / 510(k) Clearances / K951730

510(k) K951730

SPYROFOAM WOUND DRESSING by Polymedica Industries, Inc. — Product Code KMF

K951730 is an FDA 510(k) premarket notification submitted by Polymedica Industries, Inc. for the device "SPYROFOAM WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on June 16, 1995. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Polymedica Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1995
Date Received
April 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
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)

Other clearances for product code KMF

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)

FDA data resources