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510(k) K935697

Device
CIRCUMCISION TRAY
Applicant
CUSH MEDICAL PRODUCTS
510(k) number
K935697
Product code
HFX  
Decision
Substantially Equivalent - Kit With Drugs (SEKD)
Decision date
1994-05-02
Date received
1993-11-30
Regulation
884.4530
Classification name
Clamp, Circumcision
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
STEVE B JOHNSTON
Address
P.O. Box 247 881 Mountain View Dr. Piney Flats TN US 37686 37686

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251687Konig Bell Circumcision ClampMedline Industries, LP2026-02-25
K221356Wee BellWee Medical2023-02-02
K212911Konig Mogen ClampMedline Industries, Inc.2022-11-18
K151095Circumplast Circumcision DeviceNovadien Healthcare2015-09-18
K142163MALE CIRCUMCISION KITS:RAPIDECLAMPMedicfit Technology Sdn Bhd2015-04-20
K131373SHANGRINGWuhu Snnda Medical Treatment Appliance Technology2013-06-25
K121789SHANGRINGWuhu Snna Medical Treatment Appliance Technology C2012-08-03
K103695PREPEX SYSTEMCirc Medtech2012-01-10
K100916MEDICON MOGEN CLAMPMedicon EG2010-12-06
K061539GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICEClinical Innovations, LLC2007-09-20
K063429GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200Generic Medical Device, Inc.2007-01-17
K043533SURGICAL DESIGN CIRCUMCISION CLAMPSurgical Design, Inc.2005-04-01
K040052FINE SURGICAL CIRCUMCISION CLAMPFine Surgical Instrument Corp.2004-04-09
K032091SMART KLAMP VARIOUS BY SIZEEmergogroup, Inc.2004-03-08
K033403T.S. MEDICAL CIRCUMCISION CLAMPT.S. Medical2004-01-22

Legacy Summary#

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FDA Review#

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