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510(k) K941356

Device
MICROFLOW IRRIGATION SYSTEM
Applicant
JEDMED INSTRUMENT CO.
510(k) number
K941356
Product code
GBQ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-05-19
Date received
1994-03-21
Regulation
878.4200
Classification name
Catheter, Continuous Irrigation
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CRAIG R RAPP
Address
6069 Lemay Ferry Rd. St. Louis MO US 63129 63129

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K921464CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INTTrinity Laboratories, Inc.1992-05-05
K882647GESCO CATHETERIZATION TRAYGesco Intl., Inc.1988-09-09
K874596PERFORATED SOAKING TUBESpecialty Medical Products Co.1987-12-02
K873097PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKSIpax, Inc.1987-09-04
K872787MODIFIED CURLCATHQuinton, Inc.1987-08-04
K791400GASTRIC LAVAGE KIT-DISPOSABLEAcumed Instruments Corp.1979-08-16
K771732THORNTON ANTERIOR CHAMBER IRRIGATORConcept, Inc.1977-09-28

Legacy Summary#

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FDA Review#

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