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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Arthroscope
510(k) Number K864513
Device Name LP ARTHROSCOPIC THIGH HOLDING DEVICE
Applicant
Twin Falls Orthopedic Associates, P.A.
562 Shoup Ave., W.
Twin Falls,  ID  83301
Applicant Contact FREDERICK SURBAUGH
Correspondent
Twin Falls Orthopedic Associates, P.A.
562 Shoup Ave., W.
Twin Falls,  ID  83301
Correspondent Contact FREDERICK SURBAUGH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/13/1986
Decision Date 11/25/1986
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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