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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K960945
Device Name IMZ MEMBRANE TACK SYSTEM
Applicant
Interpore Intl.
181 Technology Dr.
Irvine,  CA  92618
Applicant Contact LYNN RODARTI
Correspondent
Interpore Intl.
181 Technology Dr.
Irvine,  CA  92618
Correspondent Contact LYNN RODARTI
Regulation Number872.4880
Classification Product Code
DZL  
Date Received03/08/1996
Decision Date 05/24/1996
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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