XENFORM SOFT TISSUE REPAIR MATRIX— 510(k) K051190

Name: FDA 510(k) clearance K051190
Creator: U.S. Food and Drug Administration
Published: 2005-06-10

Substantially Equivalent

Tei Biosciences, Inc.

FDA 510(k) clearance K051190 for XENFORM SOFT TISSUE REPAIR MATRIX, Substantially Equivalent on 2005-06-10. Applicant: Tei Biosciences, Inc.. Device class: 2.

Clearance details

Applicant: Tei Biosciences, Inc.
Product code: Code PAJ
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2005-05-10
Decision date: 2005-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PAJ

view all

K002233 — BVI SLING2000-10-13

More clearances from Tei Biosciences, Inc.

view all

K162965 — SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction2017-02-16
K153690 — PriMatrix Dermal Repair Scaffold2016-02-22
K131286 — PRIMATRIX DERMAL REPAIR SCAFFOLD2013-08-05
K100261 — PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD2010-12-10
K083898 — SURGIMEND2009-02-04

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