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510(k) K761338

Device
LEFF STETHOSCOPE FOR FETAL HEART
Applicant
J. SKLAR MFG. CO., INC.
510(k) number
K761338
Product code
HGN  
Decision
Substantially Equivalent (SESE)
Decision date
1977-01-12
Date received
1976-12-27
Regulation
884.2900
Classification name
Stethoscope, Fetal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
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 HGN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K813298CONPHAR DELEE HILLIS STETHOSCOPEConphar, Inc.1981-12-08

Legacy Summary#

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FDA Review#

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