FDA.reportPublic FDA data

510(k) K842015

Device
Sawyer First Aid Kit
Applicant
SAFFETA, INC.
510(k) number
K842015
Product code
KYP
Decision
Substantially Equivalent (SESE)
Decision date
1984-07-06
Date received
1984-05-18
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#

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 KYP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883839ND:YAG LASER SPECTACLES, MST MODEL #YLS-5Marlo Surgical Technology1988-12-09
K844048DR. HESSEL'S INSECT POISON REMOVERMedie Group1985-01-23
K831312LOPEZ-HORN CARRIERChiron Vision Corp.1983-05-25