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510(k) K980988

Device
AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)
Applicant
AXYA MEDICAL, INC.
510(k) number
K980988
Product code
GAB  
Decision
Substantially Equivalent (SESE)
Decision date
1998-05-11
Date received
1998-03-17
Regulation
878.4800
Classification name
Needle, Suturing, Disposable
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
HOWARD L SCHRAYER
Address
12 S. St. Marblehead MA US 01945 01945

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GAB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K012199DIGICAPHumana USA, Inc.2001-12-19
K932591ENDO-JUDGESynergistic Medical Technologies, Inc.1993-12-22
K895681CONTRAST BACKGROUND MATERIALApplied Medical Technologies1989-10-24
K863595COATED SUTURE NEEDLESharpoint, Inc.1986-10-24
K831648ANCHOR BRAND SURGICAL NEEDLESAnchor Products Co.1983-08-16
K812444RADIATION STERILIZATION FOR NEEDLE CNTRDevon Industries, Inc.1981-12-14
K801976SCANLAN STERNUM NEEDLE-SUTUREScanlan Intl., Inc.1980-09-26

Legacy Summary#

summary

FDA Review#

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