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510(k) K864426

Device
RAYLOR(TM) DEPTH GAUGE
Applicant
CEDAR SURGICAL, INC.
510(k) number
K864426
Product code
HTJ  
Decision
Substantially Equivalent (SESE)
Decision date
1986-11-26
Date received
1986-11-10
Regulation
888.4300
Classification name
Gauge, Depth
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TERRY P CORBIN
Address
15265 Minnetonka Blvd. Minnetonka MN US 55345 55345

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HTJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940480ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICEAcufex Microsurgical, Inc.1994-03-23
K925335ACUFEX INTRA ARTICULAR MEASURING DEVICEAcufex Microsurgical, Inc.1992-12-29
K873191ACROMED INTERBODY DEPTH GAUGESBuckman Co., Inc.1987-09-09

Legacy Summary#

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FDA Review#

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