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510(k) K941098

Device
Secure-site
Applicant
OP-CO MEDICAL PRODUCTS LTD.
510(k) number
K941098
Product code
KMK
Decision
Substantially Equivalent (SESE)
Decision date
1995-08-09
Date received
1994-03-09
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
JANICE COOK
Address
30 Rockefeller Plz. Rm. 5455 New York City NY US 10112 10112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K943147STATLOCK CVVenetec, Inc.1994-09-29
K943047IV START KITSSterile Concepts, Inc.1994-09-14
K941940IMMOBILE STERILE AND IMMOBILE A/C STERILETnt Moborg Intl. , Ltd.1994-07-14
K941850IMMOBILE NON-STERILE AND IMMOBILE A/C NON-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