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510(k) K943047

Device
IV START KITS
Applicant
STERILE CONCEPTS, INC.
510(k) number
K943047
Product code
KMK  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-14
Date received
1994-06-27
Regulation
880.5210
Classification name
Device, Intravascular Catheter Securement
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KAY ANDREWS
Address
5100 Commerce Rd.. Richmond VA US 23234 23234

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KMK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc.2019-07-09
K981860A P HARNESSParaworks Enterprise, Ltd.1999-06-03
K963365MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.1996-10-11
K941098SECURE-SITEOp-Co Medical Products , Ltd.1995-08-09
K943147STATLOCK CVVenetec, Inc.1994-09-29
K941850IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILETnt Moborg Intl. , Ltd.1994-07-14
K941940IMMOBILE STERILE AND IMMOBILE A/C STERILETnt Moborg Intl. , Ltd.1994-07-14
K935389CONMED VENI-GARD I.V. DRESSINGConmedcorp1994-03-07
K935252K-LOK CATHETER SECUREMENT DEVICE MODIFICATIONK-Lok, Inc.1994-02-18
K940127CENTERMARK SECURING WINGSMenlo Care, Inc.1994-02-09
K932757SECURODRIP (TM) I.V. ARMBOARDOp-Co Medical Products , Ltd.1993-12-08
K925992DUODERM TRANSPARENT HYDROCOLLOID DRESSINGConvatec, A Division of E.R. Squibb & Sons1993-10-15
K930663IV COMFORT PADD.J. Scott Mfg., Inc.1993-09-30
K922103IAB ANCHORDatascope Corp.1993-08-03
K930225K-LOK CATHETER SECUREMENT DEVICEK-Lok, Inc.1993-04-21

Legacy Summary#

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FDA Review#

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