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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
Predetermined Change
Control Plan Authorized		 No
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