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510(k) K983204

Device
HARWILL MEDICAL U-KLIP UMBILICAL CLAMP
Applicant
HARWILL MEDICAL (PTY) LTD.
510(k) number
K983204
Product code
HFW  
Decision
Substantially Equivalent (SESE)
Decision date
1999-02-26
Date received
1998-09-14
Regulation
884.4530
Classification name
Clamp, Umbilical
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
E.J. Smith
Address
P.O. Box 4341 Crofton MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K041332JOEY CLAMP OPENING TOOLMaternus, Inc.2004-06-25
K033846KAEN YIH UMBILICAL CORD CLAMPKaen Yih Enterprise Co., Ltd.2004-03-11
K020718SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILEPrecision Dynamics Corp.2002-06-03
K021055BUSSE UMBILICAL CORD CLAMP CUTTERBusse Hospital Disposables, Inc.2002-04-29
K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-BDynarex Corp.2001-11-28
K011621KOALA CLAMP, KOALA CLAMP AND CUTTERMaternus, Inc.2001-08-10
K010695KOALA CLAMPMaternus, Inc.2001-05-03
K010835POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385Busse Hospital Disposables, Inc.2001-04-30
K000227UMBICUTPollak (Intl.), Ltd.2000-04-27
K994367UMBILICAL CORD CLAMPMedical Sales Co.2000-03-17
K994263SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540Precision Dynamics Corp.2000-01-24
K990737'ECURLINE UMBILICAL CORD CLAMP #3500Precision Dynamics Corp.1999-04-06
K974227HOSPITAL'S CLAMPGps1997-12-12
K963223EZ-CIRCPhyllis Adams, Rn, Npc, Msn1997-04-23
K963889QFC UMBILICAL CLAMPQfc Industries1997-04-18

Legacy Summary#

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FDA Review#

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