KENTEX— 510(k) K953914

Substantially Equivalent

Kentron Health Care, Inc.

FDA 510(k) clearance K953914 for KENTEX, Substantially Equivalent on 1995-11-06. Applicant: Kentron Health Care, Inc.. Device class: Unclassified.

Clearance details

Applicant: Kentron Health Care, Inc.
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1995-08-21
Decision date: 1995-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFQ

K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE1999-08-12
K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S1999-06-11
K990974 — VITOP DRESSING1999-06-09
K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE1999-04-23
K984187 — CROSSTEX NON-WOVEN SPONGES1999-02-18

More clearances from Kentron Health Care, Inc.

K030693 — KENTEX DISPOSABLE VAGINAL SPECULUM2003-08-27
K971917 — KENTRON'S ISOLATION GOWN1997-09-19
K972410 — IMPERVIOUS ISOLATION GOWN1997-09-19
K953465 — KENTEMP1995-12-15
K953830 — KENSORB1995-10-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.