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510(k) K844702

GAUZE ASORBABLE by Medicon, Inc. — Product Code EFQ

K844702 is an FDA 510(k) premarket notification submitted by Medicon, Inc. for the device "GAUZE ASORBABLE". The FDA issued a decision of Substantially Equivalent on April 1, 1985. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Medicon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1985
Date Received
December 3, 1984
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 Medicon, Inc.

  • K962087 — SERVOTRONIC EC100 SYSTEM (April 23, 1997)
  • K952168 — TITANIUM MANDIBULAR FRACTURE SYSTEM (June 22, 1995)
  • K850855 — TENS GB1001 DEVICE (January 9, 1986)
  • K850852 — INFRARAX DEVICE (August 21, 1985)
  • K844573 — ABSORBABLE GAUZE PRODUCTS (March 5, 1985)
  • K844574 — WHEELCHAIRS (February 21, 1985)
  • K844703 — GOWNS, SURGICAL (January 10, 1985)
  • K844705 — SHOE COVERS (January 10, 1985)
  • K844704 — CAPS (O.R. NURSE, SURGICAL) (January 10, 1985)
  • K840034 — VACUUM STRETCHER IMMOBILIZER (February 27, 1984)

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