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510(k) K870844

Device
SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR
Applicant
WARSAW ORTHOPEDIC, INC.
510(k) number
K870844
Product code
HWB  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-13
Date received
1987-03-03
Regulation
888.4540
Classification name
Extractor
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES RITTER
Address
P.O. Box 1157 Warsaw IN US 46580 46580

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HWB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873710MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350Arthropedics, Inc.1987-11-02
K870083FERRAY EXTRACTORTerray Manufacturing, Inc.1987-02-26
K801327THE EXTRACTOR I TMThe Anspach Effort, Inc.1980-06-09
K780300HIP PLATE REMOVAL INSTRUMENTRichard'S Medical Equip., Inc.1978-02-28

Legacy Summary#

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FDA Review#

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