MACROPORE ENT RECONSTRUCTION FILM— 510(k) K012769

Name: FDA 510(k) clearance K012769
Creator: U.S. Food and Drug Administration
Published: 2001-10-25

Substantially Equivalent

Macropore Biosurgery, Inc.

FDA 510(k) clearance K012769 for MACROPORE ENT RECONSTRUCTION FILM, Substantially Equivalent on 2001-10-25. Applicant: Macropore Biosurgery, Inc.. Device class: 2.

Clearance details

Applicant: Macropore Biosurgery, Inc.
Product code: Code NHB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2001-08-17
Decision date: 2001-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHB

view all

K260620 — SeptAlign (SPLN001)2026-07-30
K251790 — SeptAlign2026-01-16
K233569 — SeptAlign2024-03-22
K223167 — Spirair Nasal Septal Strap2023-08-17
K210411 — PosiSep EAR Fragmentable Ear Dressing2022-05-05

More clearances from Macropore Biosurgery, Inc.

view all

K042261 — MACROPORE PURICEL LIPOPLASTY SYSTEM2004-09-20
K041105 — MACROPORE HYDROSORB SPINE SYSTEM2004-07-28
K031955 — MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET2003-09-22
K031785 — MACROPORE CARDIO-WRAP (TS)2003-09-04
K024169 — MACROPORE OS RECONSTRUCTION2003-07-01

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