BIOPATCH ANTIMICROBIAL DRESSING— 510(k) K003229

Name: FDA 510(k) clearance K003229
Creator: U.S. Food and Drug Administration
Published: 2001-10-26

Substantially Equivalent

Integra Lifesciences Corp.

FDA 510(k) clearance K003229 for BIOPATCH ANTIMICROBIAL DRESSING, Substantially Equivalent on 2001-10-26. Applicant: Integra Lifesciences Corp.. Device class: Unclassified.

Clearance details

Applicant: Integra Lifesciences Corp.
Product code: Code SEL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2000-10-10
Decision date: 2001-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code SEL

view all

More clearances from Integra Lifesciences Corp.

view all

K183581 — Codman Disposable Perforators2019-01-20
K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable2019-01-11
K182265 — CodMan Certas Plus Programmable Valve2018-11-20
K181902 — Codman Certas Plus Electronic Tool Kit2018-10-25
K150682 — CUSA Excel+2015-12-18

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