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510(k) K942445

Device
SYNERGY II
Applicant
SYNECTICS MEDICAL, INC.
510(k) number
K942445
Product code
MMZ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-22
Date received
1994-05-23
Regulation
876.4890
Classification name
Table, Cystometric, Electric
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID WOODRUFF
Address
1425 Greenway Dr., #600 Irving TX US 75038 75038

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MMZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K033335LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUSSiemens Medical Solutions USA, Inc.2003-11-25
K954278BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005Beta Medical Products, Inc.1995-10-02
K942485MDT UROLOGY TABLEMdt Corp., Inc.1994-08-26

Legacy Summary#

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FDA Review#

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