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510(k) K830703

Device
GLOMARK
Applicant
ALPHAMEDIX, INC.
510(k) number
K830703
Product code
FZZ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-04-28
Date received
1983-03-07
Regulation
878.4660
Classification name
Marker, Skin
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
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 FZZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042555SURGICHIP TAG SURGICAL MARKERSurgichip, Inc.2004-11-09
K915066DISPOSABLE SKIN MARKERAmerican Medical Mfg., Inc.1992-05-14
K914759BLOOM TRANSPARENT STENCILFreckles Publications, Inc.1992-04-21
K912730ROCKET SURGICAL SKIN MARKING PENWest Texas Lighthouse For the Blind1991-11-07
K905143SKIN MARKERAesculap, Inc.1991-02-06
K904559QUALTEX SKIN MARKERQualtex, Inc.1990-12-13
K896792SURGICAL SKIN MARKERWestmark, Sterile Packing Systems, Inc. (Sps)1989-12-27
K864371SURGICAL SKIN MARKERMyocure, Inc.1986-11-17
K863280DERMAMARKERDermacare Products, Inc.1986-09-09
K861772LASER SKIN MARKER AND MASK WHITE LOTIONPacific Poly Crafts1986-05-21
K844865SECURLINE SURGICAL SKIN MARKER 1000Precision Dynamics Corp.1985-01-14
K843116DISPOSABLE SKIN MARKING PENE.M. Adams1984-08-17
K841085SCANLAN COLORMARK SKIN MARKERScanlan Intl., Inc.1984-06-11
K840820SECURLINE SURGICAL SKIN MARKER 1000Precision Dynamics Corp.1984-04-25
K840470SURGISCRIBE MARKING PENSurgicot, Inc.1984-03-12

Legacy Summary#

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FDA Review#

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