LUNDEEN SUBTALAR PEG IMPLANT— 510(k) K922292

Name: FDA 510(k) clearance K922292
Creator: U.S. Food and Drug Administration
Published: 1992-10-23

Substantially Equivalent

Sgarlato Laboratories, Inc.

FDA 510(k) clearance K922292 for LUNDEEN SUBTALAR PEG IMPLANT, Substantially Equivalent on 1992-10-23. Applicant: Sgarlato Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Sgarlato Laboratories, Inc.
Product code: Code MJW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1992-05-15
Decision date: 1992-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MJW

view all

K033046 — SUBTALAR PEG IMPLANT2003-12-23

More clearances from Sgarlato Laboratories, Inc.

view all

K043204 — SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP2005-03-30
K990101 — PAIN CONTROL INFUSION PUMP1999-03-19
K982931 — THREADED FIXATION PIN1998-10-21
K926262 — FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE1994-01-26
K926237 — O'BRIEN GONIOMETER1993-08-02

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