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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K051698
Device Name MERRIES UNI-OSTEO, MODEL CS30250-CS10102
Applicant
Merries International, Inc.
2f 3-1, Bau-Hung Rd.
Shin-Tien, Taipei,  TW
Applicant Contact JESSICA LI
Correspondent
Merries International, Inc.
2f 3-1, Bau-Hung Rd.
Shin-Tien, Taipei,  TW
Correspondent Contact JESSICA LI
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/24/2005
Decision Date 09/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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