FDA.reportPublic FDA data

510(k) K042367

Device
NYLON THREADED NEEDLE
Applicant
Aros Surgical Instruments Corp.
510(k) number
K042367
Product code
GAR
Decision
Substantially Equivalent (SESE)
Decision date
2004-10-14
Date received
2004-08-31
Regulation
878.5020
Classification name
Suture, Nonabsorbable, Synthetic, Polyamide
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
GRACE HOLLAND
Address
3722 Ave. Sausalito Irvine CA US 92606 92606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K052900QUILL NONABSORBABLE NYLON BARBED SUTUREQuill Medical, Inc.2005-11-28
K052482ARTELON SURGICAL SUTUREArtimplant AB2005-10-17
K041510TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURESutures India Private Limited2005-06-02