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510(k) K971093

OPPORTUNITY I.V. START KIT by Opportunity, Inc. — Product Code MGP

K971093 is an FDA 510(k) premarket notification submitted by Opportunity, Inc. for the device "OPPORTUNITY I.V. START KIT". The FDA issued a decision of SN on September 16, 1997. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. 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
Dressing, Wound And Burn, Occlusive
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Opportunity, Inc.

  • K971089 — OPPORTUNITY, INC. LACERATION TRAY (September 16, 1997)
  • K971095 — OPPORTUNITY SUTURE REMOVAL KIT (September 16, 1997)
  • K971088 — OPPORTUNITY INCISION AND DRAINAGE TRAY (September 16, 1997)
  • K971090 — OPPORTUNITY DRESSING CHANGE TRAY (September 16, 1997)
  • K971091 — OPPURTUNITY TRACHEOSTOMY CARE 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 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