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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement Obturator
510(k) Number K853186
Device Name SILASTIC INFLATABLE BONE PLUG H.P.
Applicant
Dow Corning Corp. Healthcare Industries Materials
Technical Service & Developmen
Hemlock,  MI  48626
Applicant Contact ELDON E FRISCH
Correspondent
Dow Corning Corp. Healthcare Industries Materials
Technical Service & Developmen
Hemlock,  MI  48626
Correspondent Contact ELDON E FRISCH
Regulation Number878.3300
Classification Product Code
LZN  
Date Received07/30/1985
Decision Date 09/24/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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