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510(k) K926036

Device
ACUFEX SUTURE RETRIEVER
Applicant
ACUFEX MICROSURGICAL, INC.
510(k) number
K926036
Product code
GAE  
Decision
Substantially Equivalent (SESE)
Decision date
1993-05-05
Date received
1992-12-01
Regulation
878.4800
Classification name
Snare, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LYNNE ARONSON
Address
130 Forbes Blvd. Mansfield MA US 02048 02048

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950776BIPOLAR SNARECook Urological, Inc.1995-04-18
K903174ADVANCE SUTURE ABSORBABLE GUT SUTUREAdvance Suture, Inc.1991-07-10
K881224ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLEAcufex Microsurgical, Inc.1988-06-01

Legacy Summary#

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FDA Review#

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