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510(k) K903174

Device
ADVANCE SUTURE ABSORBABLE GUT SUTURE
Applicant
ADVANCE SUTURE, INC.
510(k) number
K903174
Product code
GAE  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-10
Date received
1990-07-18
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
DANIEL MISENHIMER
Address
P.O. Box 12428 Tucson AZ US 85732 85732

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
K881224ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLEAcufex Microsurgical, Inc.1988-06-01

Legacy Summary#

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FDA Review#

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