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510(k) K871087

Device
S.C.M.T. PERFORATOR
Applicant
SALT CREEK MEDICAL TECHNOLOGIES
510(k) number
K871087
Product code
HGE  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-23
Date received
1987-03-18
Regulation
884.4530
Classification name
Amniotome
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HOWARD MEADE
Address
5500 Arapaho Pass Pinckney MI US 48169 48169

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HGE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951148OBSTI-HOOKOnli1995-06-09
K926425AMNIPERF(TM)Raymart Development Co.1994-03-07
K910518GLOVE-N-GEL AMNIOTOMY KITEpcom Medical Systems, Inc.1991-05-09
K850758AMNIGLOVE & AMNICOTGo Medical Industries Pty. , Ltd.1985-04-15
K834177H.R. JAKOBI SURG. INSTRUMENTS #4 30/31Imm Enterprises , Ltd.1983-12-27

Legacy Summary#

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FDA Review#

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