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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K843013
Device Name H-H TENDEON IMPLANT
Applicant
Holter-Hausner Intl.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Holter-Hausner Intl.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Date Received07/31/1984
Decision Date 04/17/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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