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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Mandibular Fixator And/Or Distractor
510(k) Number K000992
Device Name MACROPOREDX DISTRACTOR SYSTEM
Applicant
Macropore Biosurgery, Inc.
6740 Top Gun St.
San Diego,  CA  92121
Applicant Contact KENNETH K KLEINHENZ
Correspondent
Macropore Biosurgery, Inc.
6740 Top Gun St.
San Diego,  CA  92121
Correspondent Contact KENNETH K KLEINHENZ
Regulation Number872.4760
Classification Product Code
MQN  
Date Received03/28/2000
Decision Date 06/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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