GAUZE SPONGE— 510(k) K895086

Substantially Equivalent

Keilei Intl., Inc.

FDA 510(k) clearance K895086 for GAUZE SPONGE, Substantially Equivalent on 1989-10-23. Applicant: Keilei Intl., Inc.. Device class: Unclassified.

Clearance details

Applicant: Keilei Intl., Inc.
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1989-08-08
Decision date: 1989-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, NJ, 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 Keilei Intl., Inc.

K913779 — BANDAGE ROLL, GAUZE1991-12-04
K912779 — GAUZE SPONGE,STERILE 2'S1991-09-30
K913575 — GAUZE PACKING, SURGICAL STERILE AND NON-STERILE1991-09-06
K895372 — X-RAY DETECTABLE GAUZE SPONGE1989-11-03

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