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510(k) K874596

Device
PERFORATED SOAKING TUBE
Applicant
SPECIALTY MEDICAL PRODUCTS CO.
510(k) number
K874596
Product code
GBQ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-12-02
Date received
1987-11-09
Regulation
878.4200
Classification name
Catheter, Continuous Irrigation
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
THOMAS J HASLAM
Address
3063 S. Davis Blvd. Bountiful UT US 84010 84010

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
K941356MICROFLOW IRRIGATION SYSTEMJedmed Instrument Co.1994-05-19
K921464CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INTTrinity Laboratories, Inc.1992-05-05
K882647GESCO CATHETERIZATION TRAYGesco Intl., Inc.1988-09-09
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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