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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 K792561
Device Name MINI-H-FIXATION
Applicant
Geny Medical, Inc.
66 Argonaut # 170
Aliso Viejo,  CA  92656
Correspondent
Geny Medical, Inc.
66 Argonaut # 170
Aliso Viejo,  CA  92656
Regulation Number888.3040
Classification Product Code
JEC  
Date Received12/12/1979
Decision Date 12/19/1979
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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