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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tendon, Passive
510(k) Number K780320
Device Name PASSIVE TENDON 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
Regulation Number888.3025
Classification Product Code
HXA  
Date Received02/24/1978
Decision Date 03/17/1978
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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