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510(k) K052387

Device
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
Applicant
ARTHREX, INC.
510(k) number
K052387
Product code
LZB  
Decision
Substantially Equivalent (SESE)
Decision date
2005-11-29
Date received
2005-08-31
Regulation
880.6250
Classification name
Finger Cot
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANN WATERHOUSE
Address
1370 Creekside Blvd. Naples FL US 34108 34108

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992539PERCUGUARDDigit-Pro2000-02-18
K980827LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELINGTucker & Associates1998-05-04
K912042BETHEL PLUS MULTIPLE NAMESBethel Latex Products, Inc.1991-07-02
K903073LATEX FINGER COTSDongkuk Trading Co., Ltd.1990-09-12

Legacy Summary#

summary

FDA Review#

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