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510(k) K920985

Device
SNOWDEN-PENCER IRRIGATION PUMP
Applicant
SNOWDEN-PENCER
510(k) number
K920985
Product code
HEI  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-09
Date received
1992-03-02
Regulation
884.2660
Classification name
Monitor, Heart-valve Movement, Fetal, Ultrasonic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BLACK, III
Address
2058 Kilman Dr. Tucker GA US 30084 30084

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HEI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K012003DRG REACTION CHAMBER/SAFETY TIPDoctor'S Research Group, Inc.2002-02-12
K910982INNERVISION IRRIGATION PUMPM.D. Engineering, Inc.1991-08-26

Legacy Summary#

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FDA Review#

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