FDA.reportPublic FDA data

510(k) K894646

Device
#556 DISPOSABLE UMBILICAL CORD CLAMP (2)
Applicant
ALPHA UNLIMITED, INC.
510(k) number
K894646
Product code
HFW  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-05
Date received
1989-07-24
Regulation
884.4530
Classification name
Clamp, Umbilical
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRENT MAGERS
Address
P.O. Box 808 701 N. Greenwood Ave. Clearwater FL US 33517 33517

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
K983204HARWILL MEDICAL U-KLIP UMBILICAL CLAMPHarwill Medical (Pty) , Ltd.1999-02-26
K974227HOSPITAL'S CLAMPGps1997-12-12
K963223EZ-CIRCPhyllis Adams, Rn, Npc, Msn1997-04-23

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases