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510(k) K971091

OPPURTUNITY TRACHEOSTOMY CARE KIT by Opportunity, Inc. — Product Code KMF

K971091 is an FDA 510(k) premarket notification submitted by Opportunity, Inc. for the device "OPPURTUNITY TRACHEOSTOMY CARE KIT". The FDA issued a decision of SN on September 16, 1997. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Opportunity, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
September 16, 1997
Date Received
March 24, 1997
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 Opportunity, Inc.

  • K971093 — OPPORTUNITY I.V. START KIT (September 16, 1997)
  • K971088 — OPPORTUNITY INCISION AND DRAINAGE TRAY (September 16, 1997)
  • K971089 — OPPORTUNITY, INC. LACERATION TRAY (September 16, 1997)
  • K971090 — OPPORTUNITY DRESSING CHANGE TRAY (September 16, 1997)
  • K971095 — OPPORTUNITY SUTURE REMOVAL KIT (September 16, 1997)
  • K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (June 11, 1997)
  • K971062 — OPPORTUNITY INC. GENERAL PURPOSE TRAY (June 9, 1997)

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