FDA.reportPublic FDA data

510(k) K770163

Device
SUTURE CUTTER
Applicant
Concept, Inc.
510(k) number
K770163
Product code
JOK
Decision
Substantially Equivalent (SESE)
Decision date
1977-03-30
Date received
1977-01-25
Regulation
880.6820
Classification name
Scissors, Medical, Disposable
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
N

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 JOK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K855131SUTURE REMOVAL KITDynarex Corp.1986-01-13
K843075UTILITY SCISSORS DISPOSABLE ITEMSGreene International Corp.1984-09-05
K812555DISPOSABLE SUTURE REMOVAL SCISSORSMedcare Products1981-11-16
K770595SUTURE REMOVAL SETAbco Dealers, Inc.1977-05-23
K770481SHEAR, PLASTIC HANDLE UTILITY S-475-7Acme United Corp.1977-04-29
K761192DRESSING CHANGE KITSuperior Plastic Products Corp.1977-02-28