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510(k) K953914

KENTEX by Kentron Health Care, Inc. — Product Code EFQ

K953914 is an FDA 510(k) premarket notification submitted by Kentron Health Care, Inc. for the device "KENTEX". The FDA issued a decision of Substantially Equivalent on November 6, 1995. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Kentron Health Care, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1995
Date Received
August 21, 1995
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 Kentron Health Care, Inc.

  • K030693 — KENTEX DISPOSABLE VAGINAL SPECULUM (August 27, 2003)
  • K971917 — KENTRON'S ISOLATION GOWN (September 19, 1997)
  • K972410 — IMPERVIOUS ISOLATION GOWN (September 19, 1997)
  • K953465 — KENTEMP (December 15, 1995)
  • K953830 — KENSORB (October 3, 1995)

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