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510(k) K863149

Device
BOWEN PROBE
Applicant
BOWEN & COMPANY, INC.
510(k) number
K863149
Product code
HXB  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-05
Date received
1986-08-15
Regulation
888.4540
Classification name
Probe
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CAROL APPLE
Address
1800 Chapman Ave. Rockville MD US 20852 20852

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960539DIAO HAND SURGERY SETKinetikos Medical, Inc.1996-07-23
K943472COHORT AVB RETRACTOR SYSTEMCohort Medical Products Group, Inc.1994-10-20
K912843FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBEFlexmedics1991-09-24
K890227SURGICAL PROBEKinetic Medical Products1989-01-27
K873651BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375Arthropedics, Inc.1987-11-02
K873652HOOK PROBE #TM-1376Arthropedics, Inc.1987-11-02
K8419712.5MM & 4MM PROBE K841969-LABELINGStainless Mfg., Inc.1984-06-19
K840558SHUTT PRECISION PROBESConcept, Inc.1984-04-25
K810294LINE CADDYInstranetics, Inc.1981-02-26
K802951I.M PROBESHogan & Hartson1980-12-17
K802479SURGICAL KNIVES & PROBESEder Instrument Co, Inc.1980-10-31
K800729PROBEStainless Mfg., Inc.1980-04-08
K800444GOLDEN RETRIEVERS OR SILVER RETRIEVERSInstrument Makar, Inc.1980-03-05
K800274ACUFEX PROBESAcufex Microsurgical, Inc.1980-02-19

Legacy Summary#

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FDA Review#

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