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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K022139
Device Name HIP TOOL IMPLANT
Applicant
ORTHOPEDIC SCIENCES, INC
4329 GRAYDON RD.
SAN DIEGO,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
ORTHOPEDIC SCIENCES, INC
4329 GRAYDON RD.
SAN DIEGO,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/02/2002
Decision Date 09/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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