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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Cement Restrictor
510(k) Number K990345
Device Name RABEA DEVICE, MODEL PXXXXXX
Applicant
Signus Medizintechnik GmbH
27660 Woodside Rd.
Shorewood,  MN  55331
Applicant Contact THOMAS HOGHAUG
Correspondent
Signus Medizintechnik GmbH
27660 Woodside Rd.
Shorewood,  MN  55331
Correspondent Contact THOMAS HOGHAUG
Regulation Number878.3300
Classification Product Code
JDK  
Date Received02/04/1999
Decision Date 07/30/1999
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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