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510(k) K861154

ALBA HEALTH CARE PLAIN PACKING STRIP by Alba Health Care — Product Code EFQ

K861154 is an FDA 510(k) premarket notification submitted by Alba Health Care for the device "ALBA HEALTH CARE PLAIN PACKING STRIP". The FDA issued a decision of Substantially Equivalent on April 15, 1986. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Alba Health Care has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1986
Date Received
March 28, 1986
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 Alba Health Care

  • K864689 — ALBA HEALTH CARE IODOFORM PACKING STRIP (January 20, 1987)
  • K851918 — INFANT PHOTOTHERAPY MASK (June 7, 1985)
  • K850904 — ALBA DRY BURN DRESSING (April 17, 1985)
  • K850881 — ALBA DRY BURN PAD (April 17, 1985)
  • K850241 — ALBA HEALTH CARE NON-ADHERING DRESSING (March 12, 1985)
  • K812904 — STERILE ORTHOPEDIC STOCKINETTE (January 18, 1982)
  • K803171 — PROCEDURE & RECOVERY PATIENT SUIT (March 4, 1981)

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