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510(k) K802248

Device
DISARP ORIGINAL
Applicant
UNOPLAST A/S
510(k) number
K802248
Product code
GAO  
Decision
Substantially Equivalent (SESE)
Decision date
1980-09-26
Date received
1980-09-16
Regulation
878.4495
Classification name
Suture, Nonabsorbable
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932513LABELING FOR MYO/WIRE II STERNOTOMY SUTURESAlto Development Corp.1994-01-07
K872532AUTO SUTURE STAINLESS STEEL SUTURES*United States Surgical, A Division of Tyco Healthc1987-08-05
K863034SHARPOINT STAINLESS STEEL SUTUREChathamborough Research Group, Inc.1986-09-30

Legacy Summary#

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FDA Review#

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