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510(k) K881224

Device
ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE
Applicant
ACUFEX MICROSURGICAL, INC.
510(k) number
K881224
Product code
GAE  
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-01
Date received
1988-03-22
Regulation
878.4800
Classification name
Snare, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RICHARD E FRANKO
Address
575 University Ave. Norwood MA US 02062 02062

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
K926036ACUFEX SUTURE RETRIEVERAcufex Microsurgical, Inc.1993-05-05
K903174ADVANCE SUTURE ABSORBABLE GUT SUTUREAdvance Suture, Inc.1991-07-10

Legacy Summary#

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FDA Review#

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