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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K894098
Device Name SYNTHES EXTERNAL FIXATION BONE CLIP
Applicant
Synthes (Usa)
1690 Russell Rd.
Post Office Box 1766
Paoli,  PA  19301
Applicant Contact SUSAN M SNYDER
Correspondent
Synthes (Usa)
1690 Russell Rd.
Post Office Box 1766
Paoli,  PA  19301
Correspondent Contact SUSAN M SNYDER
Regulation Number888.3040
Classification Product Code
JEC  
Date Received06/09/1989
Decision Date 04/30/1990
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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