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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cerclage, fixation
510(k) Number K972327
Device Name METAGEN ACTIVELOCK CERCLAGE 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 Number888.3010
Classification Product Code
JDQ  
Date Received06/23/1997
Decision Date 08/11/1997
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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