510(k) K883839

Device
ND:YAG LASER SPECTACLES, MST MODEL #YLS-5
Applicant
MARLO SURGICAL TECHNOLOGY
510(k) number
K883839
Product code
KYP  
Decision
Substantially Equivalent (SESE)
Decision date
1988-12-09
Date received
1988-09-12
Regulation
880.5740
Classification name
Snake Bite Suction Kit
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SCOTT C MARLOW
Address
1810 Joseph Lloyd Pkwy. Willoughby OH US 44094 44094

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KYP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K844048DR. HESSEL'S INSECT POISON REMOVERMedie Group1985-01-23
K842015SAWYER FIRST AID KITSaffeta, Inc.1984-07-06
K831312LOPEZ-HORN CARRIERChiron Vision Corp.1983-05-25

Legacy Summary#

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FDA Review#

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