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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Manual Surgical Instrument
510(k) Number K902819
Device Name LAMINECTOMY ROGEUR
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
LXH  
Date Received06/27/1990
Decision Date 08/09/1990
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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