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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Fixation, Spinal Intervertebral Body
510(k) Number K893415
Device Name TRANS-ORAL DEPTH GAUGE
Applicant
Ruggles Corp.
38 Billings Rd.
No. Quincy,  MA  02171
Applicant Contact ALAN RUGGLES
Correspondent
Ruggles Corp.
38 Billings Rd.
No. Quincy,  MA  02171
Correspondent Contact ALAN RUGGLES
Regulation Number888.4540
Classification Product Code
LYQ  
Date Received05/02/1989
Decision Date 06/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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