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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 K972913
Device Name MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)
Applicant
PACIFIC MATERIALS AND INTERFACES
4329 GRAYDON RD.
SAN DIEGO,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
PACIFIC MATERIALS AND INTERFACES
4329 GRAYDON RD.
SAN DIEGO,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/07/1997
Decision Date 07/30/1998
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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