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510(k) K844048

Device
DR. HESSEL'S INSECT POISON REMOVER
Applicant
MEDIE GROUP
510(k) number
K844048
Product code
KYP  
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-23
Date received
1984-10-17
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
RANDI L BRESLOW
Address
1819 He St. NW Federal Bar Bldg. Washington DC US 20006 20006

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
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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