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510(k) K971095

OPPORTUNITY SUTURE REMOVAL KIT by Opportunity, Inc. — Product Code EFQ

K971095 is an FDA 510(k) premarket notification submitted by Opportunity, Inc. for the device "OPPORTUNITY SUTURE REMOVAL KIT". The FDA issued a decision of SN on September 16, 1997. The device falls under product code EFQ (Gauze/Sponge, Internal), 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
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Opportunity, Inc.

  • K971089 — OPPORTUNITY, INC. LACERATION TRAY (September 16, 1997)
  • K971093 — OPPORTUNITY I.V. START KIT (September 16, 1997)
  • K971088 — OPPORTUNITY INCISION AND DRAINAGE TRAY (September 16, 1997)
  • K971091 — OPPURTUNITY TRACHEOSTOMY CARE KIT (September 16, 1997)
  • K971090 — OPPORTUNITY DRESSING CHANGE TRAY (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 EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)

FDA data resources