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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Alterable
510(k) Number K903485
Device Name TITANIUM MESH
Applicant
Ruggles Corp.
38 Billings Rd.
No. Quincy,  MA  02171
Applicant Contact ALLAN RUGGLES
Correspondent
Ruggles Corp.
38 Billings Rd.
No. Quincy,  MA  02171
Correspondent Contact ALLAN RUGGLES
Regulation Number882.5320
Classification Product Code
GWO  
Date Received07/31/1990
Decision Date 02/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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