GENERAL USE SYNTHETIC SPONGE (STERILE)— 510(k) K955527

Name: FDA 510(k) clearance K955527
Creator: U.S. Food and Drug Administration
Published: 1996-02-05

Substantially Equivalent

Igenics, Inc.

FDA 510(k) clearance K955527 for GENERAL USE SYNTHETIC SPONGE (STERILE), Substantially Equivalent on 1996-02-05. Applicant: Igenics, Inc.. Device class: Unclassified.

Clearance details

Applicant: Igenics, Inc.
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1995-12-04
Decision date: 1996-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFQ

view all

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 Igenics, Inc.

view all

K963134 — DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)1996-09-06
K955165 — SYNTHETIC SPONGE1996-02-05

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