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510(k) K893503

Device
SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS
Applicant
LAUREL MEDICAL CORP.
510(k) number
K893503
Product code
HFN  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-12
Date received
1989-05-05
Regulation
884.2700
Classification name
Transducer, Pressure, Intrauterine
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
E PALMQUIST
Address
607 W. Travelers Trl. Burnsville MN US 55337 55337

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250897Koala Intrauterine Pressure Catheter (IPC-5000E)Clinical Innovations, LLC2025-05-22
K974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.1998-02-19
K973746PRE-FILLED SYRINGE FOR KOALA IUPClinical Innovations, Inc.1997-11-24
K961424INTRAN 500Utah Medical Products, Inc.1996-07-10
K954955STORC INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.1996-04-17
K955443INTRAN PLUSUtah Medical Products, Inc.1996-02-20
K920375DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCERTelos Medical Corp.1992-10-27
K882224ULTRANS DISPOSABLE INTRAUTERINETelos Medical Corp.1989-10-12

Legacy Summary#

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FDA Review#

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