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510(k) K931733

Device
INTERMEDICS ORTHOPEDICS REAMERS
Applicant
INTERMEDICS ORTHOPEDICS
510(k) number
K931733
Product code
HTP  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-26
Date received
1993-04-07
Regulation
888.4540
Classification name
File
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOANN RINGER
Address
1300 E. Anderson Ln. Bldg. C Austin TX US 78752 78752

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HTP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K870842SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASPWarsaw Orthopedic, Inc.1987-05-27
K862659CONCEPT ARTHROSCOPY RASPConcept, Inc.1986-09-02
K8419814MM & 5MM FILEStainless Mfg., Inc.1984-06-19
K840492SUN-LITE BLUE SLITSuncoast Medical Manufacturers, Inc.1984-05-09

Legacy Summary#

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FDA Review#

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