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510(k) K893415

Device
TRANS-ORAL DEPTH GAUGE
Applicant
RUGGLES CORP.
510(k) number
K893415
Product code
LYQ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-07
Date received
1989-05-02
Regulation
888.4540
Classification name
Accessories, Fixation, Spinal Intervertebral Body
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALAN RUGGLES
Address
38 Billings Rd. No. Quincy MA US 02171 02171

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LYQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883784TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATEWarsaw Orthopedic, Inc.1989-04-06
K882871CASF DRILL GUIDE DG 170Terray Manufacturing, Inc.1988-09-23

Legacy Summary#

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FDA Review#

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