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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(k) Number K983360
Device Name MACROPORE PROTECTIVE SHEET
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 Number872.4760
Classification Product Code
JEY  
Date Received09/24/1998
Decision Date 03/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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